Endo-Laparoscopic Approach Versus Conventional Open Surgery in Obstructing Left-sided Colon Cancer: RCT

Colonic Neoplasms Clinical Trial

Official title:

Endo-Laparoscopic Approach Versus Conventional Open Surgery in the Management of Obstructing Left-sided Colon Cancer: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654212
• Other study ID #: Shan
• Status: Completed
• Phase: Phase 4
• First received: April 2, 2008
• Last updated: May 3, 2015
• Start date: January 2002
• Est. completion date: December 2007

Study information

• Verified date: May 2015
• Source: Pamela Youde Nethersole Eastern Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Objective: Whether temporary endoscopic decompression by Self-expanding metal stents (SEMS) could allow these patients to undergo successful laparoscopic resection (endo-laparoscopic approach) has never been previously studied. This randomized trial aims to compare this approach with emergency open surgery in the management of obstructing left-sided colon cancer.

Description:

Introduction:

First reported in 1991, laparoscopic assisted colectomy is increasingly practised world-wide. Abundant evidence exists in the literature suggesting laparoscopic assisted colectomy, when compared with its open counterpart, is associated with more favourable short-term outcomes, better cosmesis, and better patient's satisfaction. Moreover, recent reports from large-scale randomized trials support the use of this minimally invasive technique in the treatment of colorectal cancer, a malignant condition common in many parts of the world. However, around 8-29% of patients with colorectal cancer present as acute large bowel obstruction, a condition used to be considered as a contraindication to laparoscopic surgery due to poor exposure and potential hazard of injury to the distended bowel. Thus, most cases of malignant large bowel obstruction mandate an emergency open surgery to relieve the obstruction and resect the tumour, with many patients, especially those with obstructing left-sided colon cancer, ending up with temporary or permanent stoma which can adversely affect their health-related quality of life.

Self-expanding metal stents (SEMS) was first described by Dohmoto in 1991 as an endoscopic palliative alternative for treating inoperable colon cancer. Three years later, Tejero et al. published a preliminary report of using SEMS as a 'bridge' to surgery in two patients with colonic obstruction 13. Since then, a number of publications as well as systemic review have shown that endoluminal stenting is a relatively simple and safe alternative to standard surgical management of acute malignant obstruction of the left colon, thereby obviating the need of emergency surgery or colostomy. However, whether temporary endoscopic bowel decompression by SEMS could allow patients with malignant left colonic obstruction to undergo successful laparoscopic resection (endo-laparoscopic approach) has never been studied in detail before. We therefore conducted the current trial to study the outcomes of this endo-laparoscopic approach in patients with obstructing left-sided colon cancer.

Patients and Methods:

This study is a randomized controlled trial designed to evaluate the outcomes of the endo-laparoscopic approach for patients with obstructing left-sided colon cancer, using patients undergoing emergency open surgery as controls. Only patients with obstructing left-sided colon cancer were studied because of the reported high incidence of stoma creation in this condition10,11, and because a homogeneous group of patients could be ensured to facilitate comparison of the two different approaches. A single surgical team consisting of two surgeons (C.C.C. and M.K.W.L.) and one camera assistant in the case of laparoscopic resection performed all operations with the patient under general anesthesia. The study was approved by the hospital ethical committee and was not supported by any commercial funds or sponsorship.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2007
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive adult patients (aged 18 or above) presenting with clinical features of left colonic obstruction were potential candidates.

• In the absence of peritonitis, right lower quadrant tenderness or grossly distended caecum (10cm or above in maximal dimension) on plain abdominal radiograph, an urgent water-soluble single contrast enema was performed to determine the level of obstruction within 24 hours of admission.

• Patients were recruited if the lower border of an obstructing tumour was found between the splenic flexure and rectosigmoid junction.

• Informed consent was obtained from every patient recruited in the trial.

Exclusion Criteria:

• Patients who did not give informed consent

• Patients who were considered unfit for operative treatment

• Patients with previous laparotomy

• Patients with clinically palpable tumor on abdominal examination.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Procedure:
• endo-laparoscopic approach
endoluminal stenting followed by laparoscopic resection
• open approach
emergency open surgery

Locations

Country	Name	City	State
Hong Kong	Pamela Youde Nethersole Eastern Hosptial	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Pamela Youde Nethersole Eastern Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	successful one-stage operation		till end of the study	Yes
Secondary	cumulative operative time, cumulative blood loss, conversion rate, post-operative pain, cumulative length of hospital stay, operative mortality, post-operative complications, ates of permanent stoma creation,disease recurrence, survival		end of study	Yes