RecruitingACTRN12619000999134

"What Lies Beneath": Keyhole surgery after previous abdomino-pelvic surgery, and the risk of developing important scar tissue.

What Lies Beneath: Laparoscopy after previous laparotomy and laparoscopy, and the incidence of intra-abdominal adhesions


Sponsor

Dr Samantha Mooney

Enrollment

1,200 participants

Start Date

Aug 6, 2018

Study Type

Observational

Conditions

Summary

We aim to complete a prospective observational cohort study to examine the rates of intra-abdominal adhesions in women with a past history of abdomino-pelvic surgery undergoing laparoscopy for any indication at our institution. At time of consent for laparoscopy for any indication, patients will be invited to participate in this study. Our study has a pragmatic design, and patient involvement in the research will not alter their treatment course. Upon consent and enrolment, the research team will then endeavour to obtain operative notes from prior surgeries for each study subject. Data will then be entered into a secure database, noting baseline patient characteristics, year of prior surgery(ies), type and number of prior incision(s), and any known history of complications during/after the prior abdominal surgeries. Patient confidentiality will be respected as per HREC guidelines. Collection of baseline data (including prior operative history) will occur pre-operatively at time of consent to participation and upon wait-listing of the case. Intra-operative findings will be documented during the planned procedure (by way of intraoperative clinical pictures), as well as at the by completion of a brief questionnaire at the conclusion of the procedure. This questionnaire will concern the presence/absence of anterior abdominal wall adhesions, their proximity to the umbilicus, and whether omentum, bowel, or both were involved. The questionnaire will take 5 minutes. Results will be analysed following the completion of data collection (once the final enrolled participant has undergone their planned surgery). Any surgical complications will be noted either on the operative questionnaire (for immediate complications), or at the initial 1-2 month post-operative visit (for delayed complications).


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When the abdomen or pelvis has been operated on previously, scar tissue called adhesions can form inside. These adhesions can make future keyhole (laparoscopic) surgery more complicated. However, we don't yet have good information on exactly how common adhesions are, what factors make them more likely, or where they tend to develop. This observational study invites women who are already scheduled for laparoscopic surgery and who have had prior abdominal surgery to participate. During their planned surgery, the surgeon will note whether adhesions are present and where. No extra procedures are performed — the study simply documents what is found. This information will help surgeons better plan for and counsel patients about the risks of future operations. You may be eligible if you are a woman aged 18 or older who is scheduled for laparoscopic surgery for any reason and has had previous abdominal or pelvic surgery. Women who have had prior pelvic radiation therapy or whose previous surgical details cannot be found are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Many women undergoing laparoscopy have had previous abdomino-pelvic surgery, placing them at greater risk of developing intraperitoneal adhesions. Adhesions, especially to the anterior abdominal wall,

Many women undergoing laparoscopy have had previous abdomino-pelvic surgery, placing them at greater risk of developing intraperitoneal adhesions. Adhesions, especially to the anterior abdominal wall, increase the risk of visceral injury, particularly at time of laparoscopic entry and establishment of pneumoperitoneum. We aim to complete a prospective observational cohort study to examine the rates of intra-abdominal adhesions in women with a past history of abdomino-pelvic surgery undergoing laparoscopy for any indication at our institution. We suspect recruitment of cases undergoing surgery to take approximately 18 months. The time period for which prior surgical history is relevant is anytime in the patient's lifetime (that is, we will request details of any abdomino-pelvic surgeries, regardless of time proceeding repeat surgery).


Locations(5)

Mercy Hospital for Women - Heidelberg

VIC, Australia

Werribee Mercy Hospital - Werribee

VIC, Australia

Warringal Private Hospital - Heidelberg

VIC, Australia

Epworth Freemasons - Melbourne

VIC, Australia

Albury Wodonga Health - Wodonga campus - Wodonga

VIC, Australia

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ACTRN12619000999134


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