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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cheung Yui Shan, Pamela Youde Nethersole Eastern Hospital
ClinicalTrials.gov Identifier:
NCT01762254
First received: November 29, 2012
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Pain,
Postoperative Wound Complication
Procedure: incisionless laparoscopic colectomy
Procedure: conventional laparoscopic colectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Incisionless Versus Conventional Laparoscopic Colectomy for Left-sided Colonic Tumors

Resource links provided by NLM:


Further study details as provided by Pamela Youde Nethersole Eastern Hospital:

Primary Outcome Measures:
  • pain score [ Time Frame: average of 1 week ] [ Designated as safety issue: Yes ]
    participants will be followed for the pain score during the duration of hospital stay, an expected average of 1 week


Secondary Outcome Measures:
  • wound complication [ Time Frame: up to 30 days after the operation ] [ Designated as safety issue: Yes ]
    The patient will be followed for up to 30 days after the operation or till occurrence of event


Other Outcome Measures:
  • intraoperative blood loss [ Time Frame: From the start of operation till operation finished ] [ Designated as safety issue: Yes ]
    From the start of operation till operation finished

  • operative time [ Time Frame: From the start of operation till operation finished ] [ Designated as safety issue: Yes ]
    From the start of operation till operation finished

  • length of hospital stay [ Time Frame: From the date after operation to date of discharge,an expected average of within 1 week ] [ Designated as safety issue: Yes ]
    From the date after operation to date of discharge,an expected average of within 1 week


Enrollment: 70
Study Start Date: June 2009
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: incisionless laparoscopic colectomy
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
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.
Active Comparator: conventional laparoscopic colectomy
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
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

Detailed Description:

For the left-sided colorectal cancer, the investigators performed colectomy with primary anatomosis. Currently the investigators have two methods of minimal access approach to the abdominal cavity in order to complete this operation:

  1. 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
  2. Incisionless Laparoscopic Colectomy Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the Transanal Endoscopic Operation (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.

These two operations are essentially identical except for the surgical access for the delivery of specimen and insertion of anvil. Laparoscopic colectomy and the use of Transanal Endoscopic Operation(TEO)device have been practiced in the United States and Europe for over 10 years. Large scale studies in the literature have demonstrated the safety and benefits of laparoscopic colectomy for colonic tumors and the oncological outcomes have not shown to be inferior to open approach. With the use of TEO device, the investigators can perform laparoscopic colectomy without abdominal incision for those early left-sided colonic tumors and thus it can eliminate the wound-related complications theoretically. In order to find out which one is a better procedure, the investigators are carrying out a clinical trial to compare the two surgical options in their short-term and long term outcomes.The results of this study may have an impact on the care of similar patients in the future.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  1. Patient who did not give informed consent;
  2. Patient who were considered unfit for operative treatment;
  3. Patient presented as acute surgical emergencies, including intestinal obstruction, peritonitis, or pericolic abscess, etc.;
  4. Patients with metastatic diseases on preoperative work up;
  5. Patient with synchronous tumours or polyps which necessitate extended or additional resection;
  6. Patients with large bulky tumor as demonstrated on preoperative colonoscopy or computed tomography showing serosal involvement or invasion to contiguous organs.
  7. Patients with anal stenosis that precluded the insertion of TEO device
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01762254

Locations
China
Department of Surgery, Pamela Youde Nethersole Eastern Hospital
Hong Kong, China
Sponsors and Collaborators
Pamela Youde Nethersole Eastern Hospital
Investigators
Principal Investigator: Yui Shan Cheung, FRACS Department of Surgery, Pamela Youde Nethersole Eastern Hospital
  More Information

No publications provided

Responsible Party: Cheung Yui Shan, Department of Surgery, Pamela Youde Nethersole Eastern Hospital, Pamela Youde Nethersole Eastern Hospital
ClinicalTrials.gov Identifier: NCT01762254     History of Changes
Other Study ID Numbers: HKEC-2009-023
Study First Received: November 29, 2012
Last Updated: January 4, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Pamela Youde Nethersole Eastern Hospital:
pain score
complication

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 14, 2014