Prospective Randomized Trial of Hand-assisted Laparoscopic Right Hemicolectomy vs Total Laparoscopic Right Hemicolectomy

NCT00485251 | Completed Phase 4 DMC

• 1 other identifier: CShan
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The operation used for treating cancer in this location of the colon is called right hemicolectomy. Currently the investigators have two methods of minimal access approach to the abdominal cavity in order to complete this operation:

1. 1.Total Laparoscopic right hemicolectomy The operation is completed by laparoscopic instruments using video laparoscopy. At the end of the procedure, a small wound was created for the delivery of bowel and extracorporeal anastomosis.
2. 2.Hand-assisted laparoscopic right Hemicolectomy A 6.5cm incision is used to allow insertion of one of the surgeon's hands into the abdomen. The operation is completed by the surgeon's hand and laparoscopic instruments, using video laparoscopy.

Conditions

Operation Time; Pain Score; Recurrence; Survival

Keywords

operation time in minutes; pain score from 1-10; recurrence; survival

Outcome Measures

Primary Outcomes (1)

• operation time

  minutes

Secondary Outcomes (1)

• pain score, recurrence

  pain score during postoperative hospital stay, recurrence for 5 years

Study Arms (2)

1

ACTIVE COMPARATOR

hand assisted right hemicolectomy

Procedure: hand-assisted laparoscopic right hemicolectomy; Procedure: hand-assisted right hemicolectomy

2

ACTIVE COMPARATOR

laparoscopic right hemicolectomy

Procedure: total laparoscopic right hemicolectomy; Procedure: laparoscopic right hemicolectomy

Interventions

hand-assisted laparoscopic right hemicolectomy PROCEDURE

using the lap disc that allows the insertion of single and into the abdomen for operation

1

total laparoscopic right hemicolectomy PROCEDURE

using laparoscopic instruments for mobilization and dissection inside the abdomen

2

hand-assisted right hemicolectomy PROCEDURE

hand-assisted right hemicolectomy

1

laparoscopic right hemicolectomy PROCEDURE

using laparoscopic instruments for mobilization and dissection inside the abdomen

2

Eligibility Criteria

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

You may qualify if:

• Patient diagnosed to have operable carcinoma of caecum and ascending colon and hepatic flexure were potential candidates.

You may not qualify if:

• Patient who did not give informed consent;
• Patient who were considered unfit for operative treatment;
• Patient presented as acute surgical emergencies, including intestinal obstruction, peritonitis, or pericolic abscess, etc.;
• Patients with metastatic diseases on preoperative work up;
• Patient with synchronous tumours or polyps which necessitate extended or additional resection;
• Patients with tumour size larger than 6.5cm in any dimension on preoperative imaging or invasion to contiguous organs.

Sponsors & Collaborators

• Pamela Youde Nethersole Eastern Hospital: lead

Study Sites (1)

Pamela Youde Nethersole Eastern Hosptial

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hester YS Cheung, FRACS

  Department of Surgery, Pamela Youde Nethersole Eastern Hosptial, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 12, 2007
• Study Start: February 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

HK (1)