Review Article

How to Develop an Electronic Clinical Endometriosis Research File Integrated in Clinical Practice

Table 2

Recommendations for designing and reporting studies in the surgical treatment of DIE.

Title and abstract
Study typeClearly define the study type (e.g., prospective, retrospective)

Introduction
BackgroundScientific background and explanation of rationale

Methods
ParticipantsPrevious therapeutic surgery: type (diagnostic, therapeutic), number, laparoscopy or laparotomy, endometriosis-related or not
Indication for surgery: pain, child wish completed, child wish uncompleted, child wish absent
Sample size and power calculation
InterventionsEndometriosis staging according to ASRM classification; operation time; length of hospital stay; multidisciplinary team including details on which surgeon did which surgery; clear description of the surgical technique according to the following definitions: shaving: superficial peeling of bowel serosal and subserosal endometriosis (with diathermy or laser), superficial excision: selective excision of the bowel endometriosis lesion without opening of the bowel wall, full thickness disc excision: selective excision of the bowel endometriosis lesion with opening followed by closure of the bowel wall, and bowel resection anastomosis: resection of a bowel segment affected by endometriosis followed by anastomosis report type and number of concomitant procedures in detail
Follow-up periodDefine the period of follow-up (in months)
Details on the follow-up procedure (e.g., telephone interview, questionnaire, and clinical evaluation)
Patients lost during follow-up period
Pain measurementDefine the method used for pain measurement: presurgery and postsurgery, number of patients using hormonal treatment at the time of pain assessment, 11-point numerical scale for the assessment of menstrual pain (dysmenorrhea), nonmenstrual pain, dyspareunia; use of other methods (interviews, questionnaires): provide full details.
Patient-based or doctor-based
QOL measurementDefine the method used for QOL measurement (e.g., EHP-30, SF-36, and EQ-5D)
Fertility rateNumber of patients with history of infertility
Number of patients wishing to conceive passively (wish for reservation/restoration of fertility during surgery, without well-defined child wish at the time of surgery); number of patients wishing to conceive actively with a well-defined child wish in the near future; number of patients wishing to conceive actively with a well-defined child wish in the distant future
Recurrence rateDefine recurrence: (1) symptom recurrence based on patient history, but no proof of recurrence by imaging and surgery; (2) endometriosis recurrence based on imaging: in patients with or without symptoms (pain and infertility). Recurrence is then likely based on noninvasive imaging (e.g., ultrasound and MRI); (3) surgical reintervention without recurrence of endometriosis: in patients with recurrent symptoms, surgery without visual diagnosis of endometriosis, and with either normal pelvis or other abnormalities (e.g., adhesions); (4) recurrence of visual endometriosis without histological proof: during laparoscopy endometriosis is visually observed but either not biopsied or biopsied without histologically proven endometriosis; (5) recurrence of histologically proven endometriosis: during laparoscopy endometriosis is visually observed and confirmed histologically. Suspicious recurrent endometriosis is present if the criteria for categories 1 and 2 were met. Proven recurrent endometriosis is present if the criteria for categories 4 and 5 were met. Additional surgery without evidence for endometriosis is present if the criteria for category 3 are met.
Statistical methodsStatistical methods used; life table analysis methods; handling of patients lost for follow-up

Results
Histological confirmationReport degree of endometriosis invasion in bowel
Report the median length of the resected colorectal segments (in cm)
Report the median largest diameter of the lesions (in cm)
Report the number of positive margins over the number of resected bowel specimens; report the number of patients with at least one positive margin of the bowel resection specimen
ComplicationsReport all major complications and their clinical management [surgery (specify type of surgery), medical, and expectant] including rectovaginal fistulae, anastomotic leaks, postoperative stomas, abscesses, and postoperative bleedings in absolute numbers
Fertility rateReport cumulative pregnancy rate (life table analysis)
Number of women who conceived
Median time to conceive after surgery
Mode of conception: spontaneous or medically assisted conception (ovulation induction; intrauterine insemination with or without ovarian stimulation; assisted reproduction: IVF and ICSI; fresh cycle or cryocycle; egg reception or embryo reception)
Live birth rate; ectopic pregnancy rate, miscarriage rate, and clinical pregnancy rate
Recurrence rateReport cumulative recurrence rate (life table analysis)

Discussion
InterpretationInterpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision, and the dangers associated with the multiplicity of analyses and outcomes.
GeneralizabilityExternal validity of the trial findings
Overall evidenceGeneral interpretation of the results in the context of current evidence

Adapted from Meuleman et al., 2012 [27].