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

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.

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:

- 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