Prospective Randomized Trial of Incisionless Versus Conventional Laparoscopic Colectomy for Left-sided Colonic Tumors

NCT01762254 | Completed

• 1 other identifier: HKEC-2009-023
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the two surgical options in their short-term and long term outcomes in the management of early left-sided colorectal cancers. The hypothesis is that the incisionless approach will result in less postoperative pain and wound related complications.

Conditions

Pain,; Postoperative Wound Complication

Keywords

pain score; complication

Outcome Measures

Primary Outcomes (1)

• pain score

  participants will be followed for the pain score during the duration of hospital stay, an expected average of 1 week

  average of 1 week

Secondary Outcomes (1)

• wound complication

  up to 30 days after the operation

Other Outcomes (3)

• intraoperative blood loss

  From the start of operation till operation finished

• operative time

  From the start of operation till operation finished

• length of hospital stay

  From the date after operation to date of discharge,an expected average of within 1 week

Study Arms (2)

incisionless laparoscopic colectomy

ACTIVE COMPARATOR

incisionless laparoscopic colectomy: Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the TEO device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy. Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.

Procedure: incisionless laparoscopic colectomy

conventional laparoscopic colectomy

ACTIVE COMPARATOR

conventional laparoscopic colectomy: The operation is completed by laparoscopic instruments using video laparoscopy. At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler. Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis

Procedure: conventional laparoscopic colectomy

Interventions

incisionless laparoscopic colectomy PROCEDURE

Arm 1:Incisionless Laparoscopic Colectomy Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the TEO device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy. Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.

incisionless laparoscopic colectomy

conventional laparoscopic colectomy PROCEDURE

Arm 2: Conventional Laparoscopic colectomy The operation is completed by laparoscopic instruments using video laparoscopy. At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler. Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis

conventional laparoscopic colectomy

Eligibility Criteria

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

You may qualify if:

• patients \>18 years old and diagnosed to have operable left-sided colorectal cancers distal to the splenic flexure and proximal to the upper rectum 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 large bulky tumor as demonstrated on preoperative colonoscopy or computed tomography showing serosal involvement or invasion to contiguous organs.
• Patients with anal stenosis that precluded the insertion of TEO device

Sponsors & Collaborators

• Pamela Youde Nethersole Eastern Hospital: lead

Study Sites (1)

Department of Surgery, Pamela Youde Nethersole Eastern Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yui Shan Cheung, FRACS

  Department of Surgery, Pamela Youde Nethersole Eastern Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Surgery, Pamela Youde Nethersole Eastern Hospital

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: January 7, 2013
• Study Start: June 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

CN (1)