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"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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619000999134
Enrollment
790
Registered
2019-07-15
Start date
2018-08-06
Completion date
2022-12-31
Last updated
2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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).

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, 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 la

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).

Sponsors

Dr Samantha Mooney
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The participants will meet the following inclusion criteria: - Female, 18 years of age or older at time of consent to participation - Requiring and consenting to laparoscopy for any indication as determined and agreed to by both the surgeon and the participant - Prior history of laparotomy OR laparoscopy with surgical details such as type of entry/incision, indication, number of prior surgeries known o Laparotomy incisions include: suprapubic transverse incision (such as Pfannenstiel, Joel-Cohen, or Maylard incision), midline incision (sub- or supra- umbilical), Hasson entry at umbilicus and prior umbilical hernia repair procedures o Laparoscopy includes any prior 5mm or 10mm trochar insertion at the umbilicus - Capable of, and have given, informed consent to their inclusion in study after explanation of research and reading of Patient Information and Consent (PCIS) form. Authorised interpreters will be utilized when necessary to assist with the consent process for women of non-English speaking backgrounds.

Exclusion criteria

- Not consenting to participation in proposed study - Unrecoverable details of prior surgeries - Prior abdomino-pelvic radiation therapy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026