## Protocol Section
### Identification Module
**NCT ID:** NCT06311279

**Brief Title:** End to End Versus Side to End Anastomosis After Anterior Resection of Cancer Rectum

**Official Title:** End to End Versus Side to End Anastomosis After Anterior Resection of Cancer Rectum

#### Organization Study ID Info
**ID:** Soh-Med-24-03-01MD
#### Organization
**Class:** OTHER
**Full Name:** Sohag University
### Status Module
#### Completion Date
**Date:** 2025-03-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-15

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-08

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-05

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-03-15
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-08
**Study First Submit QC Date:** 2024-03-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sohag University

#### Responsible Party

**Investigator Affiliation:** Sohag University

**Investigator Full Name:** Nabil Abdelnaser Al-ameer

**Investigator Title:** assistant lecturer, physician and MD candidate

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Comparison between end to end and side to end anastomosis after anterior resection of cancer rectum and compare the outcomes of both surgical techniques. The main outcomes were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary outcomes were surgical outcomes including operative time, postoperative hospital stay, postoperative complications, reoperation, and mortality.

**Detailed Description:** During the past two decades, remarkable progress has been made in the treatment of rectal cancer. The main goal of rectal surgery for malignancy is oncologic radicality in an effort to achieve the preservation of sphincters and sexual-urinary function.The introduction of circular stapling devices is largely responsible for their increasing popularity and utilization. Sphincter-saving procedures associated to partial or total mesorectal excision (TME) for the treatment of mid and distal rectal cancer have become increasingly prevalent as their safety and efficacy have been proved. Total mesorectal excision (TME) is the best available treatment for rectal cancer. With the advancement of surgical techniques, the majority of patients with mid and upper rectal cancer can undergo a sphincter-saving TME procedure. After TME, the most widely used reconstructive technique is straight coloanal anastomosis. With the advancement of surgical technique, the local recurrence rate after rectal cancer surgery has been decreased from 25-50% to 3-8%. Naturally, it is time to focus on how to improve bowel functional outcomes and quality of life (QoL) for rectal cancer patients. However, because the sigmoid colon is usually excised during surgery which decreases the storage volume of stool, there is a common problem seriously influencing the life quality of patients, including increased tool frequency, urgency and incontinence, which is termed as anterior resection syndrome (ARS). About 19-56% of patients would suffer from ARS. Thus, the demand for a technique with better functional outcomes made surgeons modify the straight anastomotic technique. Thus, another modified anastomotic technique, side-to-end anastomosis, which has been used since 1966, has gained attention. Side-to-end anastomosis usually needs a 3-5 cm-long colonic segment. Multiple studies on the literature have shown that compared with straight anastomosis, side-to-end anastomosis has advantages in bowel functional and operative outcomes.

### Conditions Module

**Conditions:**

- Rectum Cancer

**Keywords:**

- cancer rectum

- Anastomosis

- End to end

- side to end

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Comparison between end to end and side to end anastomosis after anterior resection of cancer rectum and compare the outcomes of both surgical techniques. The main outcomes were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary outcomes were surgical outcomes including operative time, postoperative hospital stay, postoperative complications, reoperation, and mortality

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** randomized comparative clinical trial

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** the first group included patients who will have anterior resection with end-to-end anastomosis

**Intervention Names:**

- Procedure: Anterior resection of Rectal cancer

**Label:** Group A

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** the second group included patients will have anterior resection with side to end anastomosis.

**Intervention Names:**

- Procedure: Anterior resection of Rectal cancer

**Label:** Group B

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A

- Group B

**Description:** Anterior resection of cancer rectum and type of anastomosis (End to end or side to end)

**Name:** Anterior resection of Rectal cancer

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** in minutes

**Measure:** Operative time

**Time Frame:** Immediate postoperative

**Description:** yes or No

**Measure:** Anastomotic leakage

**Time Frame:** 2 weeks postoperative

**Description:** in days

**Measure:** hospital stay

**Time Frame:** 2 weeks postoperative

**Description:** yes or no

**Measure:** Mortality

**Time Frame:** 4 weeks postoperative

**Description:** in cubic centimeters

**Measure:** Anastomotic leak amount

**Time Frame:** 2 weeks postoperative

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 18 years of age to 80 years.
* Laparoscopic or open anterior resection of cancer rectum.

Exclusion Criteria:

* synchronous colorectal carcinoma
* emergency surgery
* history of colon or rectal segmental resections
* fixed rectal carcinoma who received preoperative radiotherapy

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Nabil.abdelnaser@med.sohag.edu.eg

**Name:** Nabil A Al-Ameer, MD

**Phone:** 1118416290

**Phone Ext:** 0020

**Role:** CONTACT

**Contact 2:**

**Email:** Nabil.abdelnaser@med.sohag.edu.eg

**Name:** Nabil A Al-Ameer, MD

**Phone:** 1067833019

**Phone Ext:** 0020

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Sohag

**Contacts:**

***Contact 1:***

- **Email:** Nabil.abdelnaser@med.sohag.edu.eg

- **Name:** Nabil A Al-Ameer, MD

- **Phone:** 1118416290

- **Role:** CONTACT

***Contact 2:***

- **Email:** ethics@med.sohag.edu.eg

- **Name:** Ahmed G Hassanein, MD

- **Phone:** 1552538300

- **Phone Ext:** 0020

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Sohag university

**Status:** RECRUITING

**Zip:** 82511

#### Overall Officials

**Official 1:**

**Affiliation:** Sohag University

**Name:** AbdElhafez H Mohamed, MD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Ain Shams University

**Name:** Ahmed A Ahmed, MD

**Role:** STUDY_DIRECTOR

**Official 3:**

**Affiliation:** Sohag University

**Name:** Nabil A Al-Ameer, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** Sohag University

**Name:** Emad G Mohamed, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14846

- Name: Rectal Neoplasms

- Relevance: HIGH

- As Found: Rectum Cancer

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012004

- Term: Rectal Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
