Rectal CancerNCT00651677
Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer
A study testing HAL proctectomy, "straight" laparoscopic proctectomy and Hand-assisted laparoscopic proctectomy in people with Rectal Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- HAL proctectomy, "straight" laparoscopic proctectomy and Hand-assisted laparoscopic proctectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Prospective Randomized Study Comparing Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer
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.
- Conditions
- Rectal Cancer
- Being tested
- HAL proctectomy, "straight" laparoscopic proctectomy, Hand-assisted laparoscopic proctectomy, SL Proctectomy
- Keywords
- hand assisted laparoscopy, rectal cancer, short term outcomes, straight laparoscopy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAL proctectomyProcedure or surgery
Also called Gelport
Hand-assisted laparoscopic proctectomy
"straight" laparoscopic proctectomyProcedure or surgery
"straight" laparoscopic proctectomy
Hand-assisted laparoscopic proctectomyProcedure or surgery
Also called Gelport
hand-assisted laparoscopic proctectomy
SL ProctectomyProcedure or surgery
Straight laparoscopic proctectomy
| Study group | Role | What they receive |
|---|---|---|
| HAL Proctectomy | Active comparator | Hand-assisted laparoscopic proctectomy Receives: Procedure: HAL proctectomy; Procedure: Hand-assisted laparoscopic proctectomy |
| SL Proctectomy | Active comparator | "straight" laparoscopic proctectomy Receives: Procedure: "straight" laparoscopic proctectomy; Procedure: SL Proctectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
Measured: post-operative
Secondary outcomes (3)
Adequacy of resection margins
Measured: post-operative
In-hospital mortality and morbidity
Measured: during hospitalization
urinary and sexual function
Measured: preoperative and 3-6 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startApr 2011
- Primary completionNov 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sang W Lee, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651677
- Sponsor's protocol ID
- MITT02
- Status last verified
- Apr 2011
- First submitted
- 31 Mar 2008
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Randomized Study Comparing Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer
- ClinicalTrials.gov ID
- NCT00651677
- Acronym / sponsor ID
- MITT02
- Conditions
- Rectal Cancer
- Keywords
- hand assisted laparoscopy, rectal cancer, short term outcomes, straight laparoscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAL Proctectomy | Active comparator | Procedure: HAL proctectomy, Procedure: Hand-assisted laparoscopic proctectomyHand-assisted laparoscopic proctectomy |
| SL Proctectomy | Active comparator | Procedure: "straight" laparoscopic proctectomy, Procedure: SL Proctectomy"straight" laparoscopic proctectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAL proctectomyAlso: GelportHand-assisted laparoscopic proctectomy | Procedure or surgery | HAL Proctectomy |
| "straight" laparoscopic proctectomy"straight" laparoscopic proctectomy | Procedure or surgery | SL Proctectomy |
| Hand-assisted laparoscopic proctectomyAlso: Gelporthand-assisted laparoscopic proctectomy | Procedure or surgery | HAL Proctectomy |
| SL ProctectomyStraight laparoscopic proctectomy | Procedure or surgery | SL Proctectomy |
Primary outcome
operative time
Time frame: post-operative
3 secondary outcomes
Adequacy of resection margins
Time frame: post-operative
In-hospital mortality and morbidity
Time frame: during hospitalization
urinary and sexual function
Time frame: preoperative and 3-6 months postop
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang W Lee, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAL proctectomy, "straight" laparoscopic proctectomy and Hand-assisted laparoscopic proctectomy in people with Rectal Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operative time (time frame: post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.