POP data elements pertaining to patient, device, and surgeon factors
Patient factors: pre-operative
Medical HistoryNumber of births (parity) Number of vaginal births History of Caesarean section (Y/N) Co-morbidity index (Y/N) Diabetes mellitus (Y/N) Smoking status (never, past, current) Sexual activity (Y/N) If yes, does patient have pain w/ sexual activity?Menopausal status (Y/N) Stress urinary incontinence (Y/N) Urgency urinary incontinence (Y/N) Mixed urinary incontinence (Y/N) Chronic constipation (Y/N) Receipt of hormone therapy and type (systemic oestrogen, vaginal oestrogen, other) Vaginal bulge symptoms (Y/N)
Surgical HistoryPrior hysterectomy (Y/N) If yes, type of prior hysterectomy (eg, total, supracervical) If yes, approach of prior hysterectomy vaginal, abdominal, laparoscopic/robotic) If yes, indication for prior hysterectomy Prior urogynecological mesh (Y/N) If yes, location of mesh use (sling, prolapse repair)Prior anti-incontinence surgery (Y/N) If yes, type of prior anti-incontinence surgery Prior prolapse surgery (Y/N) If yes, type of prior prolapse surgery (eg, sacrocolpopexy, etc.) Previous abdominal surgery (Y/N) If yes, type of previous abdominal surgery
ExaminationBMI (respondents can choose to enter both height & weight if they don’t have BMI available)Pelvic Organ Prolapse Quantification System (POP-Q) stage (0-IV) Compartment with greatest anatomic prolapse (anterior, posterior, apical, multiple)
Patient factors: peri-operative
ProcedureSurgery date Total operating room time in minutes ASA physical status classification status (1-5) Concomitant hysterectomy (Y/N) If yes, type of hysterectomy (total, supracervical) If yes, indication for hysterectomy (prolapse, other) Concomitant anti-incontinence procedure (Y/N) If yes, what type of anti-incontinence procedure If yes, was mesh used for midurethral sling Was mesh used for prolapse repair (Y/N) If yes, type of mesh used (permanent, absorbable, biologic) If yes, approach of mesh (abdominal/vaginal /robotic/laparoscopic (select all that apply)) If yes, compartment that mesh was placed in (posterior, anterior, apical, multiple) Type of vaginal apical vault suspension Type of abdominal apical vault suspension Was hysteropexy (apical support procedure leaving uterus in place) performed (Y/N)Anterior repair performed (Y/N) Enterocele repair performed (Y/N) Posterior repair performed (Y/N) Obliterative prolapse procedure (LeFort, vaginectomy, colpectomy) (Y/N) Complication (Y/N) If yes, select all complications that occurred (see drop down list options below) Bleeding requiring Blood Transfusion Ureteral injury Urethrotomy/Repair Vascular Injury Visceral Organ Injury (Bladder/Small bowel/Large bowel/Rectum) Mesh kit trocar injury Other operative complication/injury Aborted Procedure Conversion to Laparotomy Mesh Kit / Device Malfunction Death If yes, Clavien-Dindo Scale (respondent will select Clavien-Dindo only for the most severe complication that occurred)
DischargeRe-operation during index hospitalisation (Y/N) Discharge date (date)Discharge disposition (home, VNA, SNF, LTC, deceased, other)
Patient factors: post-operative
Short-Term Follow-Up (0–30 days)Follow-up date Early postoperative complications (includes events while in hospital and after discharge in first 30 days after surgery) (Y/N) If yes, select all complications that occurred (see drop down list options below) Cardiovascular --> if yes, branch to AMI, non-ST elevation MI, CVA, TIA, cardiac arrest Pulmonary --> if yes, branch to prolonged intubation (intubation past the PACU), ICU admission, reintubation Systemic infection --> If yes branch to: pneumonia (CXR or positive sputum cultures required), SIRS, Septic shock, sepsis, pyelonephritis, urosepsis SSI --> If yes, branch to superficial SSI, deep SSI, organ space SSI UTI --> culture proven or initiation of antibiotics for empiric treatment within 30 days of surgery Bleeding --> blood transfusion within 3 days of index surgery, hematoma requiring imaging (CT scan) or further management (IR drainage, surgical evacuation)VTE --> If yes, DVT or PE C. Diff colitis GI --> postoperative ileus, SBO Organ injury (recognised after index surgery and/or discharge) If yes, ureteral injury, bladder injury and/or perforation, bowel injury, other Fistula (lots of options) Peripheral nerve injury Vaginal cuff dehiscence Suture Exposure in Vagina Suture Erosion into Viscera Mesh Exposure in Vagina Mesh Erosion into Viscera (bladder, urethra, ureter, small bowel, large bowel, rectum, other) Foreign Body left during procedure Other Death If yes, Clavien-Dindo Scale (respondent will select Clavien-Dindo only for the most severe complication that occurred) Readmissions within 30 days (Y/N) Emergency room visits within 30 days (Y/N)
Short-Term Follow-Up (31–90 days)Follow-up date Complications noted at short-term follow-up (31–90 days) (Y/N) If yes, select all complications that occurred (see drop down list options below) Vaginal Scarring Vaginal Shortening Suture Exposure in Vagina Suture Erosion into Viscera Mesh Exposure in Vagina Mesh Erosion into Viscera (bladder, urethra, ureter, small bowel, large bowel, rectum, other) Difficulty emptying bladder/urinary retention Pelvic painDyspareunia (de novo/worsening) SSI --> If yes, branch to superficial SSI, deep SSI, organ space SSI Fistula (lots of options) Visceral organ surgical injury (options) Ileus / Bowel Obstruction Thrombotic Event Cardiac Event Pulmonary Event Neurovascular Event Peripheral Nerve Injury If yes, Clavien-Dindo Scale (respondent will select Clavien-Dindo only for the most severe complication that occurred) Readmissions within 90 days (Y/N)
Long-Term Follow-Up (>90 days)Follow-up date Complications noted at long-term follow-up (>90 days) (Y/N) If yes, select all complications that occurred (see drop down list options below) Vaginal Scarring Vaginal Shortening Suture Exposure in Vagina Suture Erosion into Viscera Mesh Exposure in Vagina Mesh Erosion into Viscera (bladder, urethra, ureter, small bowel, large bowel, rectum, other) Difficulty emptying bladder/urinary retention Urinary or bowel symptoms/problems Pelvic painDyspareunia if sexually active (de novo/worsening) Pelvic infection/abscess Bone infection Sinus tract Organ Injury/Fistula Fistula (lots of options) Ureteral injury (lots of options) If yes, Clavien-Dindo Scale (respondent will select Clavien-Dindo only for the most severe complication that occurred) Symptomatic recurrence (ie, does the patient see or feel a vaginal bulge) (Y/N) Anatomic Recurrence beyond hymen (Y/N) If yes, POP Q Stage (II, III, IV) If yes, compartment with greatest anatomic prolapse (anterior, posterior, apical, multiple)
Device factors
Unique Device ID (Unique ID for Anterior/ Posterior/ ASC/ Sling) Manufacturer, Device nameType of sutures used (absorbable, permanent, both) Suture capturing device used (eg, Capio)
Surgery factors
Trainee Involvement in surgery (Y/N) Practice Type (Academic, Private, Military, Other)Centre/Hospital identifier Hospital volume
Surgeon factors (these variables will auto-populate every time after the first entry)
National Provider Identifier (NPI)/ML# Surgeon Age Training (fellow, not fellow) Specialty (OB/GYN, Urology, General Surgery)Board certification (Y/N) Sub-specialty Certification (FPRMS, Colorectal Surgery) Surgeon volume
Note: This table originally appeared in The Women’s Health Technologies Coordinated Registry Network (WHT-CRN) report.[24]