search
Back to results

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

Primary Purpose

Pain,, Postoperative Wound Complication

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
incisionless laparoscopic colectomy
conventional laparoscopic colectomy
Sponsored by
Pamela Youde Nethersole Eastern Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, focused on measuring pain score, complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery, Pamela Youde Nethersole Eastern Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

incisionless laparoscopic colectomy

conventional laparoscopic colectomy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

pain score
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
The patient will be followed for up to 30 days after the operation or till occurrence of event

Full Information

First Posted
November 29, 2012
Last Updated
January 4, 2013
Sponsor
Pamela Youde Nethersole Eastern Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01762254
Brief Title
Prospective Randomized Trial of Incisionless Versus Conventional Laparoscopic Colectomy for Left-sided Colonic Tumors
Official Title
Prospective Randomized Trial of Incisionless Versus Conventional Laparoscopic Colectomy for Left-sided Colonic Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamela Youde Nethersole Eastern Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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: 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain,, Postoperative Wound Complication
Keywords
pain score, complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
incisionless laparoscopic colectomy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
conventional laparoscopic colectomy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
incisionless laparoscopic colectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
conventional laparoscopic colectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
pain score
Description
participants will be followed for the pain score during the duration of hospital stay, an expected average of 1 week
Time Frame
average of 1 week
Secondary Outcome Measure Information:
Title
wound complication
Description
The patient will be followed for up to 30 days after the operation or till occurrence of event
Time Frame
up to 30 days after the operation
Other Pre-specified Outcome Measures:
Title
intraoperative blood loss
Description
From the start of operation till operation finished
Time Frame
From the start of operation till operation finished
Title
operative time
Description
From the start of operation till operation finished
Time Frame
From the start of operation till operation finished
Title
length of hospital stay
Description
From the date after operation to date of discharge,an expected average of within 1 week
Time Frame
From the date after operation to date of discharge,an expected average of within 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yui Shan Cheung, FRACS
Organizational Affiliation
Department of Surgery, Pamela Youde Nethersole Eastern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Pamela Youde Nethersole Eastern Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs