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Completed

NCT Number: NCT01762254

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Pamela Youde Nethersole Eastern Hospital

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. pain score

    Time frame: average of 1 week

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

Secondary outcomes

  1. wound complication

    Time frame: up to 30 days after the operation

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

Other outcomes

  1. intraoperative blood loss

    Time frame: From the start of operation till operation finished

    From the start of operation till operation finished

  2. operative time

    Time frame: From the start of operation till operation finished

    From the start of operation till operation finished

  3. length of hospital stay

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

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

Sponsors and collaborators

Lead sponsor

Pamela Youde Nethersole Eastern Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 7, 2013
Registry last updated
Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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