Intracorporeal Versus Extracorporeal Anastomosis In Laparoscopic Right Colon Resection

NCT05077358 | Unknown

• 1 other identifier: 4-2020-1037
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

STUDY DESIGN This study is a prospective, randomized, multi-center study comparing intracorporeal versus extracorporeal anastomosis in performing laparoscopic right colectomy. The study subjects will be randomly assigned to 1. intracorporeal anastomosis (experimental group) 2. extracorporeal anastomosis (control group) with 1:1 manner. After surgery the subjects will be followed up at 1month, after then, every 3 month in total 3 years. STUDY POPULATION 1\. Screening A detailed review of the medical records will be performed to assess inclusion/exclusion criteria for all subjects who have been diagnosed with right colon tumor (malignant or benign) or benign disease (complicated diverticulitis and so on) that are subject to a right colectomy procedure. All patients who are eligible, meet the inclusion and none of the exclusion criteria of this study, will be offered enrollment into the study at each site. RISK ANALYSIS

• Laparoscopic surgery: a surgical technique where operations are performed far from their target anatomy location through small incisions normally less than 15mm.
• Extracorporeal anastomosis: the anastomosis is performed by pulling out the bowel through a laparotomy.
• Intracorporeal anastomosis: the anastomosis is performed inside the abdominal cavity with a laparoscopic technique. Specimen extraction will be done through Pfannenstiel incision or similar incision in lower abdomen.
• Procedure standardization and qualification procedure Participating surgeons should complete the learning curve of the procedure and experience at least 50 laparoscopic right colectomy. They are required to be evaluated by the quality control (QC) committee. They should submit their unedited videos of laparoscopic right colectomy and must be accepted by 2 or more of total 3 QC committee members.

Conditions

Adenocarcinoma of the Colon

Keywords

Intracorporeal anastomosis; Laparoscopic colectomy; Complete mesocolic excision with central vessel ligation; Surgical site infection

Outcome Measures

Primary Outcomes (1)

• surgical site infection

  The efficacy of the anastomosis technique is defined as a lack of surgical site infection within 30 postoperative days. 1. Superficial surgical site infection 2. Deep surgical site infection

  within 30 postoperative days

Secondary Outcomes (8)

• 3 year disease-free survival

  3 years

• Tissue morphometry

  within 30 postoperative days

• Incidence of incisional hernia within 1 year after surgery

  1 year

• Postoperative pain score in visual analogue scale

  within 7 postoperative days

• Length of postoperative hospital stay

  within 7 postoperative days

Study Arms (2)

Intracorporeal anastomosis

EXPERIMENTAL

In this group, the anastomosis is performed inside the abdominal cavity with a laparoscopic technique. Specimen extraction will be done through Pfannenstiel incision or similar incision in lower abdomen.

Procedure: Intracorporeal anastomosis

Extracorporeal anastomosis

ACTIVE COMPARATOR

In this group, the anastomosis is performed by pulling out the bowel through a laparotomy.

Procedure: Extracorporeal anastomosis

Interventions

Intracorporeal anastomosis PROCEDURE

In this group, the anastomosis is performed inside the abdominal cavity with a laparoscopic technique. Specimen extraction will be done through Pfannenstiel incision or similar incision in lower abdomen.

Intracorporeal anastomosis

Extracorporeal anastomosis PROCEDURE

In this group, the anastomosis is performed by pulling out the bowel through a laparotomy.

Extracorporeal anastomosis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Right colon tumor with indication for right colectomy (malignant disease).
• Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2)

You may not qualify if:

• Patient with a comorbid illness or condition that would preclude the use of surgery.
• Patients with cT4b tumors.
• Patients whose disease condition requires major simultaneous combined resection other than right colectomy (e.g. other intestinal resection, liver resection)
• Patients unwilling to comply with all follow-up study requirements
• Patient undergoing emergency procedures
• Obstructive disease (but, possible to enroll after stent insertion resolving obstruction)
• Impossible preoperative bowel preparation
• Metastatic disease
• Pregnant or suspected pregnancy
• Complicated inflammatory bowel disease (Crohn´s Disease, Ulcerative Colitis, Intestinal tuberculosis, Behcet's disease, Undetermined inflammatory bowel disease) that combined with intraabdominal abscess or intestinal fistula
• No Informed consent

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

Related Publications (6)

• Hellan M, Anderson C, Pigazzi A. Extracorporeal versus intracorporeal anastomosis for laparoscopic right hemicolectomy. JSLS. 2009 Jul-Sep;13(3):312-7.

  PMID: 19793468 BACKGROUND

• van Oostendorp S, Elfrink A, Borstlap W, Schoonmade L, Sietses C, Meijerink J, Tuynman J. Intracorporeal versus extracorporeal anastomosis in right hemicolectomy: a systematic review and meta-analysis. Surg Endosc. 2017 Jan;31(1):64-77. doi: 10.1007/s00464-016-4982-y. Epub 2016 Jun 10.

  PMID: 27287905 BACKGROUND

• Shapiro R, Keler U, Segev L, Sarna S, Hatib K, Hazzan D. Laparoscopic right hemicolectomy with intracorporeal anastomosis: short- and long-term benefits in comparison with extracorporeal anastomosis. Surg Endosc. 2016 Sep;30(9):3823-9. doi: 10.1007/s00464-015-4684-x. Epub 2015 Dec 10.

  PMID: 26659237 BACKGROUND

• Wu Q, Jin C, Hu T, Wei M, Wang Z. Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy: A Systematic Review and Meta-Analysis. J Laparoendosc Adv Surg Tech A. 2017 Apr;27(4):348-357. doi: 10.1089/lap.2016.0485. Epub 2016 Oct 21.

  PMID: 27768552 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Xu H, Li J, Sun Y, Li Z, Zhen Y, Wang B, Xu Z. Robotic versus laparoscopic right colectomy: a meta-analysis. World J Surg Oncol. 2014 Aug 28;12:274. doi: 10.1186/1477-7819-12-274.

  PMID: 25169141 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Byung Soh Min

CONTACT

82-10-7677-5679; BSMIN@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a prospective, randomized, multi-center study comparing intracorporeal versus extracorporeal anastomosis in performing laparoscopic right colectomy. The study subjects will be randomly assigned to: 1. Intracorporeal anastomosis 2. Extracorporeal anastomosis

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: October 14, 2021
• Study Start: April 5, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)