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WithdrawnNCT00651677Updated Jan 14, 2019

Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer

An interventional study of HAL proctectomy and "straight" laparoscopic proctectomy in Rectal Cancer, sponsored by Weill Medical College of Cornell University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-14.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
funding issues
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

We hypothesize that hand-assisted laparoscopy will overcome technical difficulties related to pure laparoscopic rectal surgery and allow surgeons to expand application of laparoscopic techniques to treating patients with rectal cancer. In this study, we plan to randomly assign patients diagnosed with rectal cancer to undergo either "standard" laparoscopic surgery or hand-assisted laparoscopic surgery. We will then compare both peri-operative and long-term outcomes of patients.

Read the detailed description

Compared to traditional open surgery, laparoscopic surgery for colon cancer results in short-term benefits such as less pain, shorter length of stay, and faster return of bowel function while maintaining equivalent oncologic outcomes. For this reason, increasing numbers of colon cancer patients are undergoing laparoscopic surgery.1-3 Similarly, there are many potential benefits to performing rectal surgery laparoscopically. Although not well documented, laparoscopic rectal surgery is under active study and may result in the usual short-term benefits associated with laparoscopic surgery. In addition, compared to open surgery, laparoscopy can provide unprecedented, unobstructed views of the rectal dissection planes even in a patient with narrow pelvis, not only for the surgeon but to the entire surgical team. Magnified views of the surgical planes allow precise and sharp dissection. The pneumoperitoneum can also help open the planes for mobilization of the mesorectum.

Despite these potential advantages, adoption of laparoscopic rectal surgery has been limited for many reasons. Although there are now several prospective randomized trials demonstrating safety and benefits associated with laparoscopic colon cancer surgery, the same benefits have not yet been clearly demonstrated for laparoscopic rectal cancer surgery.1-3 In addition, concerns about inadequate oncologic rectal dissection, anastomotic complications, and technical challenges have limited wide adaptation of laparoscopic rectal surgery.4,5 In efforts to retain the benefits of laparoscopic surgery while not compromising oncologic rectal dissection, others have advocated performing hybrid procedures in which colonic portion of the surgery is performed using the "pure" laparoscopic technique and rectal dissection is performed open through a limited low midline or Pfannestiel (low transverse) incision.6

Hand-assisted laparoscopic surgery is a technique in which the surgeon places a hand into the abdomen through an airtight access device while performing laparoscopic surgery. By placing a hand into the abdomen during laparoscopy, surgeons retain their abilities to manually retract, expose, and manually dissect, which are lost in pure laparoscopic surgery. Retention of these abilities can significantly expedite the operation. In fact, several studies have demonstrated that hand-assisted laparoscopic colon surgery results in significantly shorter operative time and less conversion to open surgery while maintain similar short-term outcomes compared to "pure" laparoscopic technique.7-9 In rectal surgery for cancer, sigmoid colon, left colon, and splenic flexure need to be mobilized in order to allow tension free anastomosis between the colon and the residual rectum. In laparoscopic proctectomy, HALS compared to SLS technique may therefore, result in shorter operative time based on colonic portion of the operation alone.

One of the technical hurdles in performing laparoscopic rectal dissection is exposure and retraction of the rectum. As one dissects down to the distal rectum, especially in patients with narrow pelvis, crowding and clashing of instruments can result in poor exposure and dissection. The only prospective randomized trial comparing results of open vs. laparoscopic surgery to include rectal cancer is CLASICC trial.3 It reported an increased circumferentially positive margin of cancer following laparoscopic rectal resection with twice as many patients in the laparoscopic group (12 %) having an involved margin as in the open group (6 %). This increased radial margin may be related to difficulty in retraction and exposure. In HALS, rectal exposure and dissection can be either performed directly through the incision using the open techniques or laparoscopically with manual assistance. This may result in equivalent oncologic outcomes as the open surgery but with shorter operative time compared to SLS technique.

A further challenge in laparoscopic rectal surgery is localization of the tumor, which is less of an issue in colon cancer where the tumor is easily visible or tattooed preoperatively. This is not possible for rectal cancer, which can pose a problem in both dissection and safe division of the rectum. Without tactile sensation it can be difficult to be sure that the stapler is below the tumor. Hand assisted laparoscopic surgery allows preservation of tactile sensation and therefore circumvent the above problem. The next step following mobilization of the rectum is division of the rectum and anastomosis. This poses a challenge for the laparoscopic surgeon for several reasons. The current laparoscopic stapling devices angulate to a maximum of 65 o making horizontal division of the rectum difficult. Morin et al reported a leak rate of 17 % below 12 cm from the anal verge and as high as 25 % in those who were not diverted following laparoscopic rectal surgery.4 Leroy et al reported a similar leak rate of 20 % in cancers below 15 cm following laparoscopic rectal surgery.5 Comparatively higher leak rates after laparoscopic rectal surgery may be related to limitations in currently available laparoscopic surgical staplers. By performing distal rectal division through the incision by using the open surgical staplers, hand-assisted laparoscopic rectal surgery may result in lower anastomotic leakage rate.

We hypothesize that hand-assisted laparoscopy may result in shorter operative time while retaining the benefits associated with laparoscopic surgery. In this study, we plan to randomly assign patients diagnosed with rectal cancer to undergo either "standard" laparoscopic surgery or hand-assisted laparoscopic surgery. We will then compare both peri-operative and long-term outcomes of patients. If our hypothesis is true, hand assisted laparoscopic approach to rectal surgery may be preferable to standard laparoscopic surgery.

02

Conditions studied

  • Rectal Cancer

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Keywords

  • hand assisted laparoscopy
  • rectal cancer
  • short term outcomes
  • straight laparoscopy
03

In context

Rectal Neoplasms

1,804 studies on the registry are indexed under Rectal Neoplasms; 520 are open to participants now.

Browse Rectal Neoplasms studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 890 studies on the registry; 164 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age > = 18 years of age
  • Histologically proven rectal cancer
  • Inferior margin of the cancer located within 15 cm from the anal verge as determined by rigid sigmoidoscopy
  • No evidence of distant metastases
  • Childbearing age women with negative pregnancy test
  • Patient is a candidate for elective rectal resection
  • The patient, or their representative, is able to understand the study and is willing to consent to participation in the study.

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years of age
  • Surgically unresectable rectal cancer
  • Patients who will require APR or hand-sewn colo-anal anastomosis
  • ASA class 4 or 5
  • Patients having additional surgical procedures which may have affect recovery
  • Child bearing age women with positive pregnancy test
  • Patients with contraindication for treatment by laparoscopy
  • Patients or their representative who are unable to understand the conditions and objectives of the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    HAL Proctectomy

    Hand-assisted laparoscopic proctectomy

    Procedure: HAL proctectomy · Procedure: Hand-assisted laparoscopic proctectomy

  • Active comparator
    SL Proctectomy

    "straight" laparoscopic proctectomy

    Procedure: "straight" laparoscopic proctectomy · Procedure: SL Proctectomy

Interventions

  • ProcedureHAL proctectomy

    Hand-assisted laparoscopic proctectomy

    Also known as: Gelport

  • Procedure"straight" laparoscopic proctectomy

    "straight" laparoscopic proctectomy

  • ProcedureHand-assisted laparoscopic proctectomy

    hand-assisted laparoscopic proctectomy

    Also known as: Gelport

  • ProcedureSL Proctectomy

    Straight laparoscopic proctectomy

06

What researchers measure

Primary outcomes

  1. operative time

    Time frame: post-operative

Secondary outcomes

  1. Adequacy of resection margins

    Time frame: post-operative

  2. In-hospital mortality and morbidity

    Time frame: during hospitalization

  3. urinary and sexual function

    Time frame: preoperative and 3-6 months postop

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Study locations

1 site
  • Sang Lee
    New York, New York 10021, United States
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2011, a primary completion of Nov 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2008
First posted
Apr 3, 2008
Start
Apr 2011
Primary completionEst.
Nov 2012
CompletionEst.
Dec 2012
Last update
Jan 14, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00651677
Responsible party
Sponsor
First posted
Apr 3, 2008
Start date
Apr 2011
Primary completion
Nov 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Jan 14, 2019

Study contacts

Sang W Lee, MD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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