Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06066931 |
| Other study ID # |
28092023 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
October 1, 2026 |
Study information
| Verified date |
October 2023 |
| Source |
Kuban State Medical University |
| Contact |
Vadim V Polovinkin, MD |
| Phone |
+79186566727 |
| Email |
vvpolovinkin[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A multicenter, cohort, randomized, controlled study is being conducted since the 1of
September, 2023 whereby the immediate and long-term results of pelvic floor and perineal
wound plastic surgery after extralevatory abdominal-perineal extirpation of the rectum will
be compared. The study is conducted on the basis of the Federal State Budgetary Educational
Institution of the Ministry of Health Care of the Russian Federation, the Department of
General Surgery at the clinical base of the State Budgetary Healthcare Institution "
Krasnodar Regional Hospital No. 1 named after Professor S.V. Ochapovsky" of the Ministry of
Health Care of the Krasnodar Territory, State Budgetary Healthcare Institution " Krasnodar
Oncological Dispensary No. 1" of the Ministry of Health Care of the Krasnodar Territory The
study included patients over 18 years old suffering from cancer of the lower ampullary rectum
with T1-T4N0-2M0 (according to the classification of malignant tumors TNM in the 8th
edition), who are scheduled for extralevatory abdominal-perineal extirpation of the rectum.
Patients are randomized into 3 groups: the first group includes patients with plastic surgery
in a simple way (Plastic surgery with local tissues), the second group includes patients with
plastic surgery with a mesh endoprosthesis and the third one includes patients with plastic
surgery in a new way.
The purpose of the study is to evaluate the effectiveness of the developed method of pelvic
floor and perineal wound plastic surgery after extralevatory abdominal-perineal extirpation
of the rectum. It is easily reproducible and provides high-quality closure of the deep and
skin defect of the perineal wound. In addition, the new method will reduce the frequency of
postoperative complications when compared with the use of conventional methods of closing the
defect of the perineum, the method improves the quality of life and provides early
rehabilitation of patients.
Study status- patients are being recruited. Number of patients selected is 150 patients. The
primary endpoint of the study is the assessment of the early postoperative period and the
frequency of postoperative complications (Flap necrosis; Suppuration; Hematoma; Bleeding;
Seroma) within 30 days from the date of surgery. The study was approved by the Independent
Ethics Committee Protocol No. 112 of 12th November, 2022.
It is planned to recruit patients within 2 years and monitor each of them for 30 days after
surgery to assess the primary endpoint and to monitor patients within 1 year to assess the
secondary endpoint. The secondary endpoint means an assessment of the frequency of late
postoperative complications (perineal fistula, abscess, hernia) and an assessment of the
quality of life within 1 year after surgery. It is planned to complete the study in 2025.
Eventually it is planned to publish the protocol of the study, the results obtained after the
recruitment of the required number of patients as well as the results of evaluation of the
primary endpoint.
Description:
The aim of the study is to improve the results of pelvic floor and perineal wound plastic
surgery after extralevatory abdominal-perineal extirpation (EAPE) of the rectum for cancer of
the lower ampullary rectum by applying a new method of plastic surgery.
Being examined according to the standards of cancer treatment of the lower ampullary part of
rectum, patients are hospitalized in the oncological surgery department. In the preoperative
period, they are randomized by the Randomizer program into 3 groups by the head of the study
on the day of surgery: the 1st Group includes patients to be made plastic surgery in a simple
way (Plastic surgery with local tissues), the 2nd Group includes patients to be made plastic
surgery with a mesh endoprosthesis and the 3rd Group includes patients to be made plastic
surgery in a new way.
Patient data, clinical trial results, and randomization results are introduced into the
Microsoft Access database.
The operation is carried out as follows: under combined endotracheal anesthesia after the
completion of the abdominal and pelvic stage of the operation ending with the mobilization of
the rectum which is carried out along the posterior wall to the level of V sacral vertebra
corresponding to the bend of the sacrum; along the anterior wall that is the level of seminal
vesicles, the upper pole of the prostate gland in men, the middle third of the vagina in
women; along the lateral walls reaching the level of the pelvic nerve plexus and finally a
single-stem colostomy is formed.
Suturing of the wound of the anterior abdominal wall with drainage of the pelvic cavity is
performed. The patient is placed on his abdomen with his legs apart - "the position of a
penknife". The operating surgeon is positioned between the patient's legs. Suturing of the
skin of the perianal area with a pouch suture is performed after surgical treatment and
limitation of the surgical area. Re-processing of the operating area is performed. It is made
a fringing incision in the perianal region from the level of the sacrococcygeal joint, along
the perianal-skin folds to the middle of the perineal seam. 2-4 sutures of wound fiber fixing
to the skin of the external gluteal region may be applied for the purpose of additional
traction in patients with severe obesity.
Cylindrical mobilization of the rectum is performed with the capture of sciatic-rectal fiber
and the external sphincter along the posterior and lateral walls. If necessary, to improve
visualization or in case of tumor invasion, the coccyx is amputated. After crossing the
sacro-rectal and anococcygeal ligaments, they are connected to the abdominal cavity. The
pelvic tendon arch is sequentially crossed along the posterolateral walls, with a transition
to the side walls and a wide cut-off of the muscle that raises the anus from the fixation
site to the sciatic bone. After mobilization of the posterior and lateral semicircles, the
drug is turned into the perineal wound and mobilization is continued along the anterior
semicircle. After removal of the rectum with a neoplasm, the part of it is sent for
histological examination. The cavity of the perineal wound is sanitized with an antiseptic
solution. The plastic stage of the operation is performed: - In group 1 patients (plastic
surgery with local tissues), a simple layer-by-layer suturing of the sciatic-anal and
subcutaneous adipose tissue is performed using nodular sutures. The skin was sewn up with
nodular sutures at the discretion of surgeons. The installation of abdominal drainage and/or
perineal drainage was left to the discretion of the surgeon.
- In group 2 patients, a mesh allograft with an adhesive coating is inserted into the bottom
of the wound, positioned horizontally between the inner surfaces of the ischial bones and
vertically between the sacrum and the vagina in women or between the sacrum and the prostate
gland in men. The mesh was sewn from behind on both sides of the coccyx or sacrum. From the
side, the mesh was attached to the remainder of the levator muscle and from the front to the
transverse muscles of the perineum. The installation of abdominal drainage and/or perineal
drainage was left to the discretion of the surgeon. The sciatic-anal and subcutaneous fat are
sutured using nodular sutures.
In group 3 patients, the plastic stage is performed as follows: on one side of the perineal
wound, a cutaneous-subcutaneous-fascial flap on the leg is cut out and deepithelized, along
the entire length of the wound, thereby forming a diamond-shaped perineal wound, plunging it
into the pelvic aperture, fixing it with single sutures to the remnants of the muscle lifting
the anus of the opposite side, and the flap width is 3-4 cm, sufficient to fill the pelvic
aperture. On the opposite side of the wound, a triangular skin-subcutaneous fascial flap is
cut out on a leg equal to the width of the previously formed diamond-shaped wound at an angle
of 60-80 degrees from the middle of the wound edge, and the sides of the triangular flap
should be equal to half the length of the edge of the diamond-shaped wound, then it is moved
and additionally fill the wound cavity with it, in condition of displacement of the apex of
the triangle flap with the top of the rhombus-wounds. The perineal wound is drained through
the contraperture. The flap and the edges of the wound are separated from the gluteal muscles
and the flap is fixed with separate skin nodular sutures to eliminate tension.
The results of the operation, the postoperative course and the quality of life are recorded
in the Microsoft Access database with subsequent statistical processing. The postoperative
wound photo is made in the day of discharge (up to 30 days after surgery).
Expected results: after completing the recruitment of patients to the comparison groups and
after statistical processing it is planned to obtain an evidence base on reducing the
frequency of early and late postoperative complications in the group with plastic surgery in
a new way.
