## Protocol Section
### Identification Module
**NCT ID:** NCT01571479

**Brief Title:** The Feasibility and Safety of a Three-Port Laparoscopic Cholecystectomy Using a 2-mm Mini-Instrument

**Official Title:** The Feasibility and Safety of a Three-Port Laparoscopic Cholecystectomy Using a 2-mm Mini-Instrument

#### Organization Study ID Info
**ID:** 2012-026
#### Organization
**Class:** OTHER
**Full Name:** Inje University
### Status Module
#### Completion Date
**Date:** 2012-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-04-05

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-04-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-04

**Type:** ACTUAL

#### Start Date
**Date:** 2010-04

**Status Verified Date:** 2012-04

#### Study First Post Date
**Date:** 2012-04-05
**Type:** ESTIMATED
**Study First Submit Date:** 2012-03-31
**Study First Submit QC Date:** 2012-04-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Inje University

#### Responsible Party

**Investigator Affiliation:** Inje University

**Investigator Full Name:** Kwan Woo Kim

**Investigator Title:** Haeundae paik hospital

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this study was to show that this technique is feasible, safe and easily reproducible and to evaluate the selection criteria for a three-port laparoscopic cholecystectomy using a 2-mm mini-port.

**Detailed Description:** Since the first four-port laparoscopic cholecystectomy (LC) was reported in 1987, various surgical options for LC have been developed. Recently, single port LC (SPLC) has been increasingly performed to minimize tissue trauma, improve cosmesis and decrease postoperative pain for patients. Some surgeons suggest that the four- or three-port LC using mini-ports could be as safe, effective, economical and cosmetic as SPLC. For this reason, the investigators started M-LC for patients with benign gallbladder disease in April 2010.

Prospectively collected data from 133 patients who underwent LC for benign gallbladder disease between April 2010 and April 2011 were retrospectively reviewed.

The patient's selection for M-LC was determined by surgeon's judgment based on 'laparoscopic surgical view' after inserting the laparoscope in the operating room.

### Conditions Module

**Conditions:**

- Gallbladder Disease

**Keywords:**

- laparoscopic cholecystectomy

- mini-instrument

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 133

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** M-LC is three-port laparoscopic cholecystectomy using a 2-mm mini-instrument.

**Intervention Names:**

- Procedure: 2- mini-instrument

**Label:** 2-mm mini-instrument (M-LC)

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** C-LC is conventional three port laparoscopic cholecystectomy

**Label:** conventional instrument(C-LC)

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 2-mm mini-instrument (M-LC)

**Description:** The patient was positioned in the supine position with the head and right side up.

Under general anesthesia, pneumoperitoneum (12 mmHg) was established after an 11-mm port was placed through 11-mm transumbilical incision by the open method.

A 10-mm 0-degree laparoscope was inserted through this umbilical port. A 5-mm trocar was then placed in the epigastric area, and the surgeon determined through 'laparoscopic surgical view' whether the 2-mm mini-instrument could be used as the right subcostal port . If the 2-mm mini-instrument could be used as the right subcostal port, a 2-mm trocar was inserted . If not, a 5-mm trocar was inserted for the right subcostal port. Therefore, this point is the unique difference between the two groups.

**Name:** 2- mini-instrument

**Other Names:**

- micro-instrument

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of participants with complications or open conversion to M-LC

**Time Frame:** one year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* all patients required laparoscopic cholecystectomy for benign gallbladder diseases.

Exclusion Criteria:

* open cholecystectomy

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Busan

**Country:** Korea, Republic of

**Facility:** University of Inje College of Medicine, Haeundae Paik Hopsital

**Zip:** 612-030

#### Overall Officials

**Official 1:**

**Affiliation:** University of Inje College of Medicine, Haeundae Paik Hopsital

**Name:** kwan woo kim

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Aprea G, Coppola Bottazzi E, Guida F, Masone S, Persico G. Laparoendoscopic single site (LESS) versus classic video-laparoscopic cholecystectomy: a randomized prospective study. J Surg Res. 2011 Apr;166(2):e109-12. doi: 10.1016/j.jss.2010.11.885. Epub 2010 Dec 22.

**PMID:** 21227454

**Citation:** Bisgaard T, Klarskov B, Trap R, Kehlet H, Rosenberg J. Microlaparoscopic vs conventional laparoscopic cholecystectomy: a prospective randomized double-blind trial. Surg Endosc. 2002 Mar;16(3):458-64. doi: 10.1007/s00464-001-9026-5. Epub 2001 Nov 16.

**PMID:** 11928028

**Citation:** Chow A, Purkayastha S, Aziz O, Pefanis D, Paraskeva P. Single-incision laparoscopic surgery for cholecystectomy: a retrospective comparison with 4-port laparoscopic cholecystectomy. Arch Surg. 2010 Dec;145(12):1187-91. doi: 10.1001/archsurg.2010.267.

**PMID:** 21173293

**Citation:** Curcillo PG 2nd, Wu AS, Podolsky ER, Graybeal C, Katkhouda N, Saenz A, Dunham R, Fendley S, Neff M, Copper C, Bessler M, Gumbs AA, Norton M, Iannelli A, Mason R, Moazzez A, Cohen L, Mouhlas A, Poor A. Single-port-access (SPA) cholecystectomy: a multi-institutional report of the first 297 cases. Surg Endosc. 2010 Aug;24(8):1854-60. doi: 10.1007/s00464-009-0856-x. Epub 2010 Feb 5.

**PMID:** 20135180

**Citation:** Edwards C, Bradshaw A, Ahearne P, Dematos P, Humble T, Johnson R, Mauterer D, Soosaar P. Single-incision laparoscopic cholecystectomy is feasible: initial experience with 80 cases. Surg Endosc. 2010 Sep;24(9):2241-7. doi: 10.1007/s00464-010-0943-z. Epub 2010 Mar 3.

**PMID:** 20198490

**Citation:** Elsey JK, Feliciano DV. Initial experience with single-incision laparoscopic cholecystectomy. J Am Coll Surg. 2010 May;210(5):620-4, 624-6. doi: 10.1016/j.jamcollsurg.2009.12.030.

**PMID:** 20421017

**Citation:** Franklin ME Jr, Jaramillo EJ, Glass JL, Trevino JM, Berghoff KR. Needlescopic cholecystectomy: lessons learned in 10 years of experience. JSLS. 2006 Jan-Mar;10(1):43-6.

**PMID:** 16709356

**Citation:** Gagner M, Garcia-Ruiz A. Technical aspects of minimally invasive abdominal surgery performed with needlescopic instruments. Surg Laparosc Endosc. 1998 Jun;8(3):171-9.

**PMID:** 9649038

## Annotation Section

### Unposted Annotation

#### Event: RELEASE

- Date: 2012-04-05

- Date Unknown: Unknown

#### Event: RESET

- Date: 2012-05-02

- Date Unknown: Unknown

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001660

- Term: Biliary Tract Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M8823

- Name: Gallbladder Diseases

- Relevance: HIGH

- As Found: Gallbladder Diseases

- ID: M4946

- Name: Biliary Tract Diseases

- 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

### Condition Browse Module - Meshes

- ID: D000005705

- Term: Gallbladder Diseases

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2012-04-05

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2012-04-05

- Reset Date: 2012-05-02

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
