A randomized clinical trial to compare two different approaches in women with chronic pelvic pain. Randomized clinical trial of two laparoscopic treatments of endometriomas: cystectomy versus drainage and coagulation. A randomized clinical trial on the benefit of adhesiolysis in patients with intraperitoneal adhesions and chronic pelvic pain. Acute nonspecific abdominal pain: A randomized, controlled trial comparing early laparoscopy versus clinical observation. Addition of laparoscopic uterine nerve ablation to laparoscopic bipolar coagulation of uterine vessels for women with uterine myomas and dysmenorrhea. Laparoscopy and reported pain among patients with endometriosis. A randomized controlled trial of medroxyprogesterone acetate and psychotherapy for the treatment of pelvic congestion. Laparoscopic diagnosis of acute lower abdominal pain in women of reproductive age. Laparoscopic adhesiolysis in patients with chronic abdominal pain: a blinded randomised controlled multi-centre trial.
One hundred six patients with chronic pelvic pain were randomly allocated to one of two treatment groups. In the standard-approach group, organic causes of pelvic pain were excluded first and diagnostic laparoscopy was routinely performed. If no somatic cause could be found, attention was given to other causes such as psychological disturbances. In the second group an integrated approach was chosen. From the beginning equal attention was devoted to somatic, psychological, dietary, environmental, and physiotherapeutic factors. In this group, laparoscopy was not routinely performed. Both groups were similar with respect to clinical characteristics of the patients and the severity of their pain as assessed by various pain parameters. Postcoital pain was reported by 27% of the patients. Twenty percent of the patients had had negative sexual experiences such as childhood sexual abuse or rape. Evaluation of the pain 1 year after the institution of treatment revealed that the integrated approach improved pelvic pain significantly more often than the standard approach for three out of four pain parameters (P less than .01). Laparoscopy played no important role in the treatment of pelvic pain. It is concluded that equal attention to both organic and other causative factors from the beginning of therapy is more likely to result in a reduction of pelvic pain than is a standard approach. To assess the efficacy of two laparoscopic methods for the management of endometriomas with regard to pain relief, pregnancy rate, and disease recurrence.
                Prospective, randomized clinical trial.
                Tertiary care hospital.
                Sixty-four patients with advanced stages of endometriosis.
                Patients were randomly allocated at the time of laparoscopy to undergo either cystectomy of the endometrioma (group 1) or drainage of the endometrioma and bipolar coagulation of the inner lining (group 2).
                Pain relief and pregnancy rate.
                Thirty-two patients were enrolled in each group. The 24-month cumulative recurrence rates of dysmenorrhea, deep dyspareunia, and nonmenstrual pelvic pain were lower in group 1 than in group 2 (dysmenorrhea: 15.8% versus 52.9%; deep dyspareunia: 20% versus 75%; nonmenstrual pelvic pain: 10% versus 52.9%). The median interval between the operation and the recurrence of moderate to severe pelvic pain was longer in group 1 than in group 2 (19 months [range, 13.5-24 months] versus 9.5 months [range, 3-20 months]). The 24-month cumulative pregnancy rate was higher in group 1 than in group 2 (66.7% versus 23.5%).
                For the treatment of ovarian endometriomas, a better outcome with a similar rate of complications is achieved with laparoscopic cystectomy than with drainage and coagulation. To see whether surgical adhesiolysis would improve pelvic pain in women with pelvic adhesions.
                Randomized clinical trial comparing surgery (adhesiolysis) with no surgery with final analysis of results after 9-12 months.
                Department of Gynecology, Leiden University Medical Center, the Netherlands.
                48 women known by laparoscopy to have stage II-IV pelvic adhesions.
                Midline laparotomy and surgical adhesiolysis.
                Pelvic pain assessed by the McGill pain score, subjective pain assessment and disturbance of daily activities.
                24 women were randomly allocated to undergo surgical adhesiolysis and 24 to a control group who did not have surgery. After 9-12 months there were no significant differences between the two groups overall with regard to pelvic pain. A subgroup of women with severe, vascularized and dense adhesions involving bowel (stage IV) had significantly less pelvic pain after adhesiolysis for two of the three methods of assessment.
                Adhesiolysis for the treatment of pelvic pain is not indicated in women with light or moderate degree pelvic adhesions. It may be beneficial in those with severe adhesions involving the intestinal tract. To evaluate, in a prospective, randomized, single-institution trial, the role of early laparoscopy in the management of nonspecific abdominal pain (NSAP) in young women.
                Women aging from 13 to 45 years, admitted for NSAP at the emergency department, were included in the study. Exclusion criteria were pregnancy, previous appendectomy, contraindications to laparoscopy, diagnosis of malignancy, or chronic disease. NSAP was defined as an abdominal pain in right iliac or hypogastric area lasting more than 6 hours and less than 8 days, without fever, leukocytosis, or obvious peritoneal signs and uncertain diagnosis after physical examination and baseline investigations including abdominal sonography. Patients were randomly assigned to early (<12 hours from admission) laparoscopy group (LAP) or to clinical observation group (OBS). After discharge a follow-up was carried out.
                From January 2001 to February 2004, 508 female patients without previous abdominal surgery were evaluated in admitting area for acute right iliac or hypogastric abdominal pain, in 373 patients diagnosis was established for obvious signs or with baseline investigations. Of the remaining 135 patients, 31 were excluded from study for various reasons, 53 patients were randomly assigned to LAP and 51 to OBS. Groups were similar for age, mean BMI, white blood cell count, and duration of pain. During hospitalization diagnosis was established in 83.4% of the LAP and in 45.1% of OBS (P < 0.05). Twenty patients of OBS (39.2%) were operated during observation because of worsening of symptoms or appearance of peritoneal sign. Diagnoses in LAP were appendicitis in 16 patients (30.1%), pelvic inflammatory disease in 7 (13.2%), carcinoid in 1 (1.9%), other in 18 (33.9%), no diagnosis in 11 (20.7%); diagnoses in OBS were appendicitis in 3 patients (5.8%), pelvic inflammatory disease in 8 (15.6%), other in 12 (23.5%), and no diagnosis in 28 (54.9%). Mean length of hospital stay was 3.7 +/- 0.8 days in LAP and 4.7 +/- 2.4 days in OBS (P < 0.05); no differences were found regarding mortality, morbidity, radiation dose, and analgesia. Mean follow-up time was 29.3 months (range, 12-60 months) for LAP and 30.6 months for OBS (range, 12-60 months). After 3 months from discharge, 20% of patients in LAP and 52% in OBS had recurrent abdominal pain (P < 0.05); after 12 months, 16% in LAP and 25% in OBS (P = not significant). Six patients in OBS required readmission for surgery.
                Compared with active clinical observation, early laparoscopy did not show a clear benefit in women with NSAP. A higher number of diagnosis and a shorter hospital stay in the LAP group did not led to a significant reduction in symptoms recurrences at 1 year. To assess the effectiveness of laparoscopic uterine nerve ablation (LUNA) in women with dysmenorrhea caused by uterine myomas treated by laparoscopic bipolar coagulation of uterine vessels (LBCUV).
                Prospective, randomized, longitudinal study (Canadian Task Force classification II-1).
                Private practice, university-affiliated hospital.
                Eighty-five women with uterine leiomyomas and associated dysmenorrhea.
                Laparoscopic bipolar coagulation of uterine vessels with or without LUNA.
                Of 85 patients who entered the study, 41 were assigned to undergo LBCUV-LUNA (group A), which was successful in 40 (97.6%). In 44 women assigned to have LBCUV only (group B), 43 (97.7%) underwent successful surgery. Eighty women completed 1-, 3-, and 6-month follow-up (38 group A, 42 group B). The groups did not differ significantly in age, history of abdominopelvic surgery, intraperitoneal adhesions, endometriosis, concomitant surgery, and operating time. Seven (18.4%) of 38 women in group A and 12 (28.6%) of 42 in group B experienced lower abdominal pain postoperatively. Acceptable pain was defined as a score of zero or 1: 31 and 30 women in groups A and B reported scores of zero; 3 and 2 reported scores of 1; 4 and 8 reported scores of 2; zero and 2 reported scores of 3; and no patients reported scores of 4. The frequency and severity of postoperative pain were less in group A than in group B (both p <0.05). The efficacy of both methods was almost equal in shrinking the uterus and dominant myoma, and in improving menorrhagia and bulk-related symptoms. Dysmenorrhea improvement was 84.2% and 61.9% in groups A and B at 3 months and 92.1% and 73.8% at 6 months, respectively. This was more significant in group A than in group B (p <0.05).
                Our results suggest that LUNA may decrease postoperative ischemic pain and improve dysmenorrhea associated with uterine myomas treated by LBCUV. To compare the effectiveness of sharp excision of endometriosis with sham surgical excision in alleviating endometriosis-associated pain for up to 1 year following surgery.
                Patients requiring a laparoscopy for severe pelvic pain were eligible. If endometriosis was visually identified at laparoscopy, a biopsy of a representative lesion was taken. The women were then randomized either to have all remaining endometriosis excised with laparoscopic scissors (the excision group) or to have no further surgical treatment (the control group). Patients were asked to complete daily pain scales for 1 month preoperatively and quarterly for 1 year postoperatively. Subjects were blinded to their treatment allocation for 1 year.
                Twenty-nine women underwent laparoscopy and biopsy and were randomized to have excision or no treatment of endometriosis. The excision and control groups were similar in age, parity, and revised American Society for Reproductive Medicine stage of disease. Sixteen women completed the full year of follow-up: 9 in the excision group, and 7 in the control group. Overall, recorded pain was significantly reduced at 1 year (P < 0.05), with no significant difference between the excision and control groups.
                Laparoscopy with diagnostic biopsy alone is associated with a significant reduction in pain for up to 1 year postoperatively. Although the study lacked sufficient statistical power to exclude an effect of excision, pain relief in each group was similar. These results indicate a potential benefit of sham surgical procedures in assessing novel surgical interventions. The value of medroxyprogesterone acetate (MPA) and of psychotherapy in the treatment of lower abdominal pain due to pelvic congestion was assessed in a randomized controlled trial. Eighty-four women with abnormal pelvic venography were assigned to one of four treatment groups: MPA alone, MPA plus psychotherapy, placebo alone, and placebo plus psychotherapy. Women were treated for 4 months and thereafter followed up regularly for 9 months with pain assessments, pelvic ultrasound scanning, and hormone measurements. During treatment, MPA showed a significant benefit in terms of a reduction in visual analogue scale pain score, with 73% of women reporting at least 50% improvement compared with 33% of those treated with placebo. At 9 months after the end of therapy there was no overall significant effect of MPA or psychotherapy, but there was an interaction between MPA and psychotherapy, with 71% of the women in this group showing a greater than or equal to 50% reduction in pain score. Therapy with MPA is a useful first-line therapy for women with pain associated with demonstrable pelvic congestion. To compare the accuracy of laparoscopy performed within 24 h of admission and the conventional method based on clinical observation in the etiological diagnosis of non-specific acute lower abdominal pain (NSLAP) in women of reproductive age.
                A total of 110 patients who met the selection criteria and were seen from November 1997 to June 2000 at the Instituto Materno Infantil, a referral hospital for maternal and perinatal care in Bogotá, were randomly divided into two groups. The effectiveness of each method was evaluated according to number of diagnoses reached, length of in-patient stay before diagnosis, complications, and diagnostic accuracy when compared with a standard given by microbiological and histopathological findings as well as clinical course.
                The early laparoscopy group did not experience more accurate diagnoses (85% vs. 79%, P=0.61) or a greater number of complications (11% vs. 9%, P=0.48), although the patients' stay was shorter (1.3 vs. 2.3 days, P=0.008) than the stay of the conventional-diagnosis group. Sensitivity analysis showed more accurate judgements with laparoscopy in four of the five NSLAP causes, but only in two of the cases did this greater accuracy have clinical significance.
                Early laparoscopy did not show a clear benefit in women with NSLAP. Laparoscopic adhesiolysis for chronic abdominal pain is controversial and is not evidence based. We aimed to test our hypothesis that laparoscopic adhesiolysis leads to substantial pain relief and improvement in quality of life in patients with adhesions and chronic abdominal pain.
                Patients had diagnostic laparoscopy for chronic abdominal pain attributed to adhesions; other causes for their pain had been excluded. If adhesions were confirmed during diagnostic laparoscopy, patients were randomly assigned either to laparoscopic adhesiolysis or no treatment. Treatment allocation was concealed from patients, and assessors were unaware of patients' treatment and outcome. Pain was assessed for 1 year by visual analogue score (VAS) score (scale 0-100), pain change score, use of analgesics, and quality of life score. Analysis was by intention to treat.
                Of 116 patients enrolled for diagnostic laparoscopy, 100 were randomly allocated either laparoscopic adhesiolysis (52) or no treatment (48). Both groups reported substantial pain relief and a significantly improved quality of life, but there was no difference between the groups (mean change from baseline of VAS score at 12 months: difference 3 points, p=0.53; 95% CI -7 to 13).
                Although laparoscopic adhesiolysis relieves chronic abdominal pain, it is not more beneficial than diagnostic laparoscopy alone. Therefore, laparoscopic adhesiolysis cannot be recommended as a treatment for adhesions in patients with chronic abdominal pain.
The range of proven effective interventions for chronic pelvic pain remains limited and recommendations are based largely on single studies. Given the prevalence and healthcare costs associated with chronic pelvic pain in women, randomised controlled trials of other medical, surgical and psychological interventions are urgently required.Chronic pelvic pain is common in women in the reproductive and older age groups and it causes disability and distress that result in significant costs to health services. The pathogenesis of chronic pelvic pain is poorly understood. Often investigation by laparoscopy reveals no obvious cause for the pain. There are several possible explanations for chronic pelvic pain including undetected irritable bowel syndrome, and central sensitisation of the nervous system. A vascular hypothesis proposes that pain arises from dilated pelvic veins in which blood flow is markedly reduced. As the pathophysiology of chronic pelvic pain is not well understood, its treatment is often unsatisfactory and limited to symptom relief. Currently the main approaches to treatment include counselling or psychotherapy, attempts to provide reassurance using laparoscopy to exclude serious pathology, progestogen therapy such as with medroxyprogesterone acetate and surgery to interrupt nerve pathways.