Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06077318 |
Other study ID # |
Huadong hernia |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 20, 2023 |
Est. completion date |
December 20, 2023 |
Study information
Verified date |
October 2023 |
Source |
Fudan University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Parastomal hernia (PSH) is difficult to manage, with high rates of post-operative recurrence
and complication. Keyhole and Sugarbaker are the most commonly used techniques in the
surgical repair of the PSH. However, the efficacy and safety of the two surgical methods have
not been adequately compared in the East Asian population.
Patients diagnosed with PSH who underwent Sugarbaker or Keyhole repair from August 2012 to
August 2022 will be included. Patient demographic data and postoperative outcomes will be
retrospectively analyzed. The primary outcome measure is the recurrence rate at one year
follow-up time.
Description:
Consecutive patients undergoing surgical PSH repair in the Hernia Center of Huadong Hospital
Affiliated to Fudan University from August 2012 to August 2022 were included in this study.
Huadong Hospital undertakes surgical treatment of complex hernia and abdominal wall diseases
in Shanghai, China. The surgical records and clinical data of patients will be
retrospectively analyzed. Due to the retrospective design of the study, the patient's
informed consent was waived. The study was conducted following the ethical standards set out
in the 1964 Declaration of Helsinki and its later amendments.
The patient's surgical strategy was made by the center's experienced colorectal surgeons or
specialists in the department of hernia and abdominal wall surgery. In surgical practice,
preference is given to the laparoscopic approach, while open surgery is chosen in cases of
severe abdominal adhesions. The following three aspects of clinical data were recorded: (1)
patients' demographic data, such as age, sex, the primary disease for the stoma, body mass
index and comorbidities; (2) Surgical details: repair technique, size of abdominal wall
defect, duration of the surgical procedure; (3) Short-term and long-term postoperative
outcomes: the primary outcome is the recurrence rate at one year follow-up time, while the
secondary outcomes were length and cost of the hospitalization, and rates of the intensive
care unit admission, chronic pain, surgical site infection (SSI), re-admission and
re-operation rates within 30 days after surgery, major complications after surgery, and
surgery-related death.
Only PSH patients who received intraperitoneal onlay Sugarbaker and Keyhole mesh were
included. These patients were scheduled for follow-up appointments at the outpatient clinics,
specifically at 1 month, 3 months, and 1 year after surgery. If recurrence is suspected by
the surgeon after a physical examination, the patient would be requested for an abdominal CT
scan. During the CT scan, patients were asked to perform the Valsava maneuver to facilitate
the identification of any potential recurrences through imaging. Postoperative major
complications were defined as complications requiring hospitalization after surgery to the
one-year follow-up time. Patients with follow-up periods of less than one year were excluded
from the cohort. Recorded death, recurrence, or loss to follow-up were considered to be the
endpoint.