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Trial registered on ANZCTR


Registration number
ACTRN12619000999134
Ethics application status
Approved
Date submitted
9/10/2018
Date registered
15/07/2019
Date last updated
15/07/2019
Date data sharing statement initially provided
15/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
"What Lies Beneath": Keyhole surgery after previous abdomino-pelvic surgery, and the risk of developing important scar tissue.
Scientific title
What Lies Beneath: Laparoscopy after previous laparotomy and laparoscopy, and the incidence of intra-abdominal adhesions
Secondary ID [1] 296290 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adhesions 309962 0
Gynaecological Surgery 310133 0
Condition category
Condition code
Surgery 308738 308738 0 0
Other surgery
Renal and Urogenital 308879 308879 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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).
Intervention code [1] 312620 0
Diagnosis / Prognosis
Comparator / control treatment
As our study subjects, we aim to enroll 900 women with a past history of one or more abdominopelvic surgeries, who are undergoing laparoscopic gynaecological surgery for any indication. We will also include 300 women who have no previous abdominal or pelvic surgeries as ‘control’ subjects. 'Control' patients will not have a abdomino-pelvic surgical history, and thus we will not ned to source data from prior hospitals. Surgical histories for women in the 'comparator' group will be sourced from Australian institutions. It is likely that most women in our cohort will be <60years of age, and thus most surgical records will be from 1970 onwards. It is possible that it is more difficult to access older records. Overseas operation reports will not be sought.
Control group
Active

Outcomes
Primary outcome [1] 307727 0
Percentage of women with adhesions involving the anterior abdominal wall, with particular reference to adhesions at the umbilicus, according to number and type of previous incision? This will be assessed by laparoscopic examination.
Timepoint [1] 307727 0
Analysis will occur at the conclusion of recruitment, which is expected to be at the conclusion of 2019. For each participant, we will assess their prior surgical history preoperatively, and then assess intraoperatively for the presence of anterior abdominal adhesions, and potential risk to organs depending on route of entry utilised.
Secondary outcome [1] 352655 0
Percentage of women at risk of bowel injury upon laparoscopic entry at the umbilicus following previous abdominopelvic surgery. This will be assessed by laparoscopic examination.

Timepoint [1] 352655 0
Analysis will occur at the conclusion of recruitment, which is expected to be at the conclusion of 2019. For each participant, we will assess their prior surgical history preoperatively, and then assess intraoperatively for the presence of anterior abdominal adhesions, and potential risk to organs depending on route of entry utilised.
Secondary outcome [2] 372273 0
Percentage of women undergoing laparoscopic entry at an alternative entry site (not the umbilicus) who suffer a complication as a result of the alternative entry. This will be assessed via a study-specific questionnaire to be completed by the primary surgeon (immediate complications), and collection of clinical data at post-operative appointment(s). Complications include: operative haemorrhage, visceral damage, wound infection etc.
Timepoint [2] 372273 0
Analysis will occur at the conclusion of recruitment, which is expected to be at the conclusion of 2019.
Secondary outcome [3] 372274 0
Percentage of women undergoing a laparoscopic procedure who suffer a surgical complication (either immediate or delayed). This will be assessed via a study-specific questionnaire to be completed by the primary surgeon (immediate complications), and collection of clinical data at post-operative appointment(s). Complications include: operative haemorrhage, visceral damage, wound infection etc.
Timepoint [3] 372274 0
Analysis will occur at the conclusion of recruitment, which is expected to be at the conclusion of 2019. 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
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria

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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
An electronic database [Microsoft® Excel, 2017] will be created and utilised for storage of information obtained in the study. Information stored will be able to be transferred across to GraphPad Prism 6 software (GraphPad Software, La Jolla, CA) for statistical analysis.

Statistical analysis will include simple descriptive data for such details as baseline details and operative history. Comparative data will be tested for normal distribution and statistically analysed as appropriate. When two groups are analysed, either an unpaired t-test (parametric) or a Mann-Whitney test (non-parametric) will be used. Categorical variables will be assessed using chi-squared test. When three or more groups are compared a 1-way ANOVA (for parametric data) or Kruskal-Wallis test (for non-parametric data) will be employed. If possible, logistical regression will be used to explain the relationship between the presence/absence of umbilical adhesions (binary variable) and one or more or prior history variables: number, type, and indication for incision.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12123 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [2] 12124 0
Werribee Mercy Hospital - Werribee
Recruitment hospital [3] 12125 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [4] 12126 0
St John of God Hospita, Geelong - Geelong
Recruitment hospital [5] 12127 0
Epworth Freemasons - Melbourne
Recruitment hospital [6] 12228 0
Albury Wodonga Health - Wodonga campus - Wodonga
Recruitment postcode(s) [1] 24292 0
3084 - Heidelberg
Recruitment postcode(s) [2] 24293 0
3030 - Werribee
Recruitment postcode(s) [3] 24294 0
3220 - Geelong
Recruitment postcode(s) [4] 24295 0
3002 - Melbourne
Recruitment postcode(s) [5] 24408 0
3690 - Wodonga

Funding & Sponsors
Funding source category [1] 300880 0
Other Collaborative groups
Name [1] 300880 0
Australian Gynaecological and Endoscopy Surgery Society Ltd
Address [1] 300880 0
YRD Event Management
PO Box 717 Indooroopilly
QLD 4068 AUSTRALIA
Country [1] 300880 0
Australia
Primary sponsor type
Individual
Name
Dr Samantha Mooney
Address
Mercy Hospital for Women
Endosurgery Department
163 Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 300444 0
None
Name [1] 300444 0
Address [1] 300444 0
Country [1] 300444 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301655 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 301655 0
Natasha Rooney
Administrative Officer,
Human Research Ethics Committee
Mercy Hospital for Women
Level 6, 163 Studley Road
Heidelberg Vic 3084
Ethics committee country [1] 301655 0
Australia
Date submitted for ethics approval [1] 301655 0
15/12/2017
Approval date [1] 301655 0
18/07/2018
Ethics approval number [1] 301655 0
HREC 2018-002

Summary
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).
Trial website
N/A
Trial related presentations / publications
Nil as yet
Public notes
The rates of vascular and visceral injury sustained at time of laparoscopy are well recognised, and complicate approximately 0.1-1% of laparoscopic surgeries (MacCordick et al, 1999; Molloy et al, 2002; Liu et al, 2009; Lawson, 2015). A particularly at-risk time of procedure occurs upon entry and establishment of pneumoperitoneum, when approximately a third to a half of these injuries occur (Chapron et al, 1999; Harkki-Siren and Kurki 1997; Jansen et al, 1997), regardless of entry technique. For both closed and open entry techniques, protection to the bowel is usually afforded by the elevation of the abdominal wall and mobility of the bowel. If bowel or omentum are adherent to this point of entry, this protection is lost.

Prior studies from 15 – 40 years ago (Weibel and Manjo, 1973; Childers et al, 1993; Marret et al, 1998; Audebert and Gomel, 2000; Lam and Pun, 2002;) indicate rates of adhesions following abdominal incisions of 15-90% (predominantly based on prior laparotomy), but these studies are negatively impacted by retrospective design (some), small sample sizes (precluding multivariate analysis and adequate relative risk assessment), and lack of clear comment regarding bowel involvement within adhesions and cumulative risk following multiple laparoscopies or laparotomy. Varma and Gupta (2008) report that while almost 50% of surgeons surveyed would chose an alternative laparoscopic entry point to the umbilicus for women with a past history of midline laparotomy, the great majority would make no such alteration for women with single or multiple prior suprapubic laparotomy or umbilical laparoscopy. We plan to prospectively assess adhesions after previous abdominopelvic surgery, in an effort to better stratify risk for these patients undergoing laparoscopy after prior surgery. We are interested to primarily assess whether there is a threshold for which entry at an alternative site (for example, the left upper quadrant) should be recommended (McDonald et al, 2005). Unfortunately, there is a dearth of quality contemporary data assessing this issue. Significant findings may therefore direct future surgical practice, guiding clinicians with regards to planning a safer entry point for patients with prior abdominal incisions.

Contacts
Principal investigator
Name 87678 0
Dr Lenore Ellett
Address 87678 0
Mercy Hospital for Women
Endosurgery Department
163 Studley Road
Heidelberg VIC 3084
Country 87678 0
Australia
Phone 87678 0
+61 3 84584444
Fax 87678 0
Email 87678 0
lellett@mercy.com.au
Contact person for public queries
Name 87679 0
Dr Samantha Mooney
Address 87679 0
Mercy Hospital for Women
Endosurgery Department
163 Studley Road
Heidelberg VIC 3084
Country 87679 0
Australia
Phone 87679 0
+61 3 8458 4444
Fax 87679 0
Email 87679 0
smooney@mercy.com.au
Contact person for scientific queries
Name 87680 0
Dr Samantha Mooney
Address 87680 0
Mercy Hospital for Women
Endosurgery Department
163 Studley Road
Heidelberg VIC 3084
Country 87680 0
Australia
Phone 87680 0
+61 3 8458 4444
Fax 87680 0
Email 87680 0
smooney@mercy.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results