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Prospective study of reconstructing pelvic floor with GORE-TEX Dual Mesh
(ePTFE) in abdominoperineal resection
CUI Ji, MA Jin-ping, XIANG Jun, LUO Yan-xin, CAI Shi-rong, HUANG Yi-hua,
WANG Jian-ping and HE Yu-long
Keywords:
reconstruction,
pelvic
floor,
GORE-TEX
Dual
Mesh
(ePTFE),
abdominoperineal resection，rectal cancer
Department of Colonic and Rectal Surgery, The First Affiliated Hospital, Sun Yat-sen
University, Guangzhou, Guangdong 510080, China
Department of Colonic and Rectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen
University, Guangzhou, Guangdong510080, China
Correspondence to: Prof. He Yu-long, Department of Colonic and Rectal Surgery, The
First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510080, China
(Tel: 86-20-87755766-8211. Fax: 86-10-87331438. Email: [email protected])
Abstract
Background Mesh reconstruction has been proved to be an effective method in
incisional hernia repairment. This study is designed to evaluate the effect of
reconstructing the pelvic floor with the high-inlay expanded Polytetrafluoroethylene
(ePTFE) GORE-TEX Dual Mesh (WLGore And Associates, Flagstuff, USA) in
abdominoperineal resection.
Methods Sixty patients who underwent abdominoperineal resection for rectal cancer
were randomized into 2 groups. The pelvic peritoneum was closed by routine sutures in
group 1 and reconstructed with ePTFE in group 2. Postoperative complications and
related items were evaluated and the patients were followed up.
Results Time of confining to bed, bowel function recovery, fasting, and detaining
drainage were significantly different between two groups (P<0.05). In group 1, three
patients developed bowel obstruction (10%), while no bowel obstruction was observed in
group 2.
Conclusions Reconstruction of the pelvic floor by using ePTFE results in quicker
postoperative recovery and could decrease the risk of postoperative intestinal obstruction.
Colorectal cancer (CRC) is the most commonly diagnosed cancer and the sixth cause of c
ancer related death among Chinese population. Rectal cancer comprises 60% to 70% of
all CRC, and three fourth of rectal cancer are located below the peritoneal reflection [1].
The abdominoperineal resection (Miles surgery) was first performed for rectal cancer
resection by Miles in 1908 [2]. After that, anterior resection (Dixon surgery) and Miles
surgery were considered to be the golden standard for rectal cancer radical resection.
Though more and more operation methods were applied in rectal cancer resection with
the development of modern surgery so as to conserve the anus, Miles surgery is still one
of the most effective methods for rectal cancer radical resection [3]. However, how to
avoid short-term and long-term complications, especially bowel obstruction due to pelvic
presacral space left by abdominoperineal resection, was still a controversial issue. In
recent years, hernia repair mesh has been extensive applied in incisional hernia
repairment and proved to be highly effective. In this study, we were inspired to perform
“peritoneal reconstruction” of pelvic floor with synthetic material, high-inlay expanded
polytetrafluoroethylene (ePTFE) GORE-TEX Dual Mesh (WLGore And Associates,
Flagstuff, USA) in abdominoperineal resection, to valuate its effectiveness as well as
postoperative complications .
METHODS
Patients
From Jan 2005 to Jan 2006, 60 patients (35 males and 25 females) who underwent
abdominoperineal resection for rectal cancer were prospectively randomized into two
groups by using random number table as well as thinking of willing principle before
operation. Their age varied from 36 to 78 years. The exclusion criteria were as follow: (1)
patients had documented disseminated disease at the time of entering the study; (2)
patients with prior history of prostate disease; (3) Primary tumor stage considered to be
T4 before surgery according to imaging tests such as CT or EUS.
Operation methods
Bowel preparation, intravenous antibiotics and anesthetic induction were similar in all
cases. In group1, pelvic peritoneum was sutured and closed using routine intermittent
method with 4-0 silk sutures. In group 2, pelvic peritoneal reconstruction was performed
with ePTFE, whose smooth surface was fixed towards peritoneal cavity. Surgical
procedures were as follows: The shape and size of the entrance of lesser pelvis was
measured first. The ePTFE patch (size: 10 cm × 15 cm) was prepared and cut into the
shape similar to the entrance of the small pelvis. The edge of the patch was 1.0 cm-1.5
cm extending the edge of lesser pelvic entrance. Absorbable 2-0 Vicryl suture (Ethicon
Inc, USA) was used in fixing the patch to pelvic soft tissue with intermittent method. The
needle interval was about 1.0 cm -1.5 cm and the patch had to maintain certain tension
after the suture (Figure 1). Irrigation of the peritoneal cavity was performed to remove
blood clots and reduce pollution. The omentum was pulled down to separated the
intestines from abdominal wall before closing the incision. No drainage was placed inside
peritoneal cavity. The levator muscles and perineal tissues were approximated. A
double-lumen drain was left in the dependent portion of the pelvis and brought out
through the perineum. Extraperitoneal sigmoidostomy was performed in all patients.
Postoperative managements
Postoperative managements were as follows: Prophylactic antibiotics were intravenously
given for three days in all patients. Patients of group 1 were confined to bed with urinary
catheter detained for seven days. Oral diet was allowed after the resumption of intestinal
function. Double lumen drainage and the stitches of perineal wound were removed on
14th postoperative day before the patient discharged. Patients of group 2 were advised to
adopted semi-sitting position for six hours after operation and allowed to get up to walk
and have liquid to semi-liquid intake at the second day. Urinary catheter was removed
after urinating training for there days. Patients were discharged after removal of the
double lumen drainage at the 7th day and advised to come back to out-patient clinic for
stitches removal one more week later. All the patients had regular follow-up.
Postoperative conditions and complications such as bowel obstruction were documented
in both groups.
Statistical analysis
Values with normal distribution were expressed as mean ± standard deviation (SD);
values with other distributions were expressed as median and range. Continuous
non-paired variables were tested with t test. Associations between the discrete variables
were assessed with two-sided Fisher’s exact test or Pearson’s chi square tests. Statistical
analysis was performed via SPSS 13.0 software. P value less than 0.05 was considered to
reveal statistically significant difference.
RESULTS
Surgical outcomes
In these 2 groups, the median age was 56 and 58 years respectively, when the durations of
operation was 220-300 minutes (mean time: 260 minutes) and 230-300 minutes (mean
time: 270 minutes), respectively. The differences of the ages and operation time were not
statistically significant (P> 0.05). No death occurred in perioperative period in either
group. There was no significant difference in items of primary tumor T stage and sizes
between two groups. Postoperative recovery was summerized in the following table
(Table 1). Time of confining to bed, bowel function recovery, fasting, and detaining
drainage were significantly different between two groups (P<0.05).
Table 1. Comparison of postoperative recovery in patients underwent routinely pelvic
peritoneal closure and mesh reconstruction after abdominoperineal resection (days).
Postoperative Conditions
Group 1
Group 2
t
P value
value
Bed confining time
7.00±1.20
2．25±1.00 15.08 <0.0001
Urinary catheter retaining time
9.00±1.56
5.00±1.60
6.20
<0.001
Mean time of bowel function resumption 5.00±1.10
2.50±1.00
2.26
0.036
Drainage retaining time
15.00±2.56 7.26±2.20
5.26
<0.001
Mean hospitalized days
16.56±2.20 8.34±2.00
7.20
<0.001
During hospitalization, one patient in group 1 was re-operated due to acute strangulated
intestinal obstruction, which was proved to be pelvic internal intestinal hernia.
Follow-up results
Postoperative follow-up period was 12-24 months, with an average length of 18 months.
The 1-year follow-up rate and survival rate were both 100% . One patient in group 1 was
re-operated due to acute strangulated intestinal obstruction 1 month after the operation,
which was proved to be pelvic internal hernia. Another case in group 1 was re-admitted to
the hospital three times for incomplete adhesive bowel obstruction on the 4th, 10th, 12th
postoperative month . This patient was managed effectively by conservative treatment but
still felt intermittent abdominal distention. No bowel obstruction occurred in group 2
(χ2=1.40, P=0.25). All the patients received pelvic CT scans 3 months after the
operation. The images indicated that patients of group1 had intestines adhering to the
pelvis but not falling below the sutured pelvic floor. No shifting of the patch or fluid was
found in either abdomen or presacral area in patients of group 2, with intestine on above
the mesh. No patient complained of abdominal pain or distension or perineal discomfort.
DISCUSSION
The incidence of postoperative bowel obstruction after abdominoperineal resection was
reported to range from 2.8% to 8.0% [4], when the overall incidence in this series was
5.0%. The main causes of intestinal obstruction were the internal hernia from the lateral
gap of the stoma loop, pelvic internal hernia due to pelvic peritoneum dehiscence and
intestinal adhesion [5]. Patients in the series had extraperitoneal tunnel sigmoidostomy to
eliminate the gap of the lateral perineum and the outcomes were satisfying. Disposing
factors included postoperative coughing, insufficient gastrointestinal decompression,
dysuria, and flatulence due to the narrowing or distortion of the stoma or other reasons.
Patient’s early semi-sitting or sitting up and early oral diet after operation also led to
increase in the intra-abdominal pressure (IAP). Increased IAP and gravity would bring
increased pressure to local gaps and the sutures. The intestine herniating to the gaps or
breaking through the suture line could form an internal hernia and cause bowl obstruction.
In addition, too strong vacuum force of the presacral suction drainage was also likely to
cause herniation [6]. Intestinal adhesion and narrowing or distortion of the stoma could
also lead to bowel obstruction.
How to manage pelvic peritoneum after abdominoperineal resection was still
controversial [7-8]. Some believe that closing the pelvic peritoneum could prevent
intestine from falling down into pelvis and causing adhesion;while the others consider
reluctant suture of the pelvic perineum with too much tension as a cause of incomplete
peritoneal closure or suture dehiscence , which would predispose the intestine to break
through the gap and form adhesive obstruction. The latter opinion was reflected by the
surgical procedure which left pelvic peritoneum wide open and let the intestine falling to
fill the pelvic space. However, if future adhesive obstruction occurs in pelvic space,
surgery will be rather difficult. Additionally, those patients who underwent postoperative
radiotherapy could be more prone to radiative intestinal injury if part of their intestine
was piling in pelvics. It was reported that satisfying closure of peritoneum was crucial in
preventing internal hernia [9]. Moderate tension should be maintained while suturing,
with proper stitch intervals. Continuous suture was recommended and adjacent structure
like omentum and uterus could be used for closure when sewing tension was high. Pelvic
peritoneum could be left open if too much pelvic peritoneum was excised and the closure
of the peritoneum was difficult to achieve.
However, even with satisfying closure, the pelvic peritoneum might only have limited
capacity of resisting the intra-abdominal pressure after abdominoperineal resection, as it
had lost the support from its surrounding tissues and organs. Thus, how to reconstruct or
repair a strong pelvic peritoneum was under heated investigation and debate. Ideal
implant material should be of adequate strength, biological inert, non-carcinogen,
stability against infection and no adhesion. In our study, three patients had intestinal
obstruction in group 1, with the morbidity of 10%. In 2 cases it was later confirmed that
pelvic internal hernia resulting from dehiscence of pelvic peritoneum was the cause. In
comparison, no bowel obstruction occurred during hospitalization and within one year
after operation in group 2. Although the above results were found to be of no statistical
significant difference, which might due to the limited objects in present research. they did
suggest a lower morbidity of postoperative intestinal obstruction in group 2. On the other
hand, Time of confining to bed, bowel function recovery, fasting, and detaining drainage
were significantly different between two groups (P<0.05).
Sugarbaker et al reported using patients’ own materials, such as omentum and bladder for
pelvic peritoneal reconstruction, but there were some drawbacks such as the procedure
was difficult and the rebuilt "pelvic peritoneum" was not strong enough, etc [10].
Devereux et al had also reported reconstruction of pelvic peritoneum with Polyglycolic
acid mesh, which effectively prevent the small intestine from falling down to pelvic space
[11]. However, the mesh was not applied widely around the world. Sezeyr A et al once
used silicon synthetic materials to pack the pelvic space, but had to remove them later
because they were susceptible to infection [12].
In recent years, synthetic materials such as Polypropylene patch and ePTFE patch were
successfully ultilized in repairing inguinal hernia and abdominal incisional hernia. These
materials, especially the GORE - TEX Dual Mesh (ePTFE), were found to be helpful in
reconstructing the pelvic peritoneum [13-15]. ePTFE patch, in which the micropore was
less than 3 microns in diameter in visceral surface, could reduce adhesions and allow
direct exposure to intestines. On the other side of the mesh, with an average pore
diameter of 22 microns, allowed the host cells to grow into the patch. Animal
experiments [16-18] and clinical studies [19-21] indicated that it was very safe to place
ePTFE within the peritoneum. One research showed that ePTFE has the advantage of
anti-infection effect to some extent, thus it’s not prone to infection [22]. Since the patch
could provide stronger support than peritoneum, the small intestine would not herniate
through the peritoneal floor even in the face of gravity and increased intra-abdominal
pressure due to coughing or intestinal bloating.
As no digestive tract reconstruction was performed in abdominoperineal resection, early
oral diet was allowed. It was beneficial to the postoperative convalescence, and could
reduce the incidence of adhesive obstruction as well. Therefore, patients in group 2 had
shorter time of bedridden, bowel function resumption, fasting, and urinary catheter and
drainage detaining. Moreover, earlier postoperative ambulation and resuming diet fasten
the recovery of bowel function, while self-voiding and patent presacral drainage could
promote wound healing, which correspondingly decreased the cost of hospitalization.
Patients having or suspected to have residual tumor could receive radial therapy as soon
as possible.
More studies and long-term follow-up were required to evaluate the prolonged
effectiveness of ePTFE in pelvic peritoneal reconstruction, and to investigate the
condition between the ePTFE and tissue growth.
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Figure 1. The pelvic floor reconstruction was performed using GORE-TEX Dual Mesh
(ePTFE).