Double-layered anterior colporrhaphy (DAC)-video and mid-term follow-up of 60 patients.

INTRODUCTION AND HYPOTHESIS: Anterior colporrhaphy (AC) exhibits high recurrence rates, and this issue is not appropriately addressed by alloplastic material, which often necessitates reoperation. Aiming to improve the anatomical cure rate, we implemented double-layered anterior colporrhaphy (DAC). With a retrospective investigation, precise description and video of the surgical technique, we want to contribute to the development of native tissue anterior repair.
METHODS: Women treated by DAC and vaginal hysterectomy were included. Primary outcome was anatomic cure defined as prolapse < stage 2. Secondary outcomes were complication rate, resolution of postvoid residual urine, reoperation for prolapse and patient satisfaction. Follow-up encompassed a clinical gynecologic examination, the German Pelvic Floor Questionnaire and a response scale for postoperative quality of life (QoL). The key difference between DAC and AC is the continuous suture followed by the traditional interrupted sutures.
RESULTS: One hundred one patients were eligible, and 60 patients attended follow-up. Cure was achieved in 49 cases (81.7%) of cystocele with a median follow-up of 19.3 months. Fifty-five patients (91.7%) indicated an improvement in QoL.
CONCLUSIONS: We observed high anatomic cure rate and satisfaction after DAC. With description and video of the technique, it is reproducible and comparable to other methods. Randomized controlled trials should follow.

Introduction

In most cases, anterior colporrhaphy (AC) exhibits high recurrence rates. While use of alloplastic material lowers recurrence rates, it is also accompanied by complications such as mesh erosion and de novo dyspareunia, frequently requiring reoperation [1]. Therefore, alloplastic material is not recommended for the primary surgical approach.

Consequently, we need to develop surgical techniques that yield long-lasting results without relying on alloplastic material. In the process, a particular focus should be placed on standardization of operation technique and reporting. Halpern-Elenskaia et al. [2] emphasized this challenge when they reported on 40 randomized controlled trials (RCT) and found no detailed description of AC and differences in each step of the procedure. Fairclough et al. [3] came to similar conclusions when they analyzed the native tissue anterior repair techniques of 30 surgeons in the UK.

Some authors recommend, depending on the severity of the prolapse, two rows of traditional horizontal plication or a purse-string suture preceding the traditional plication [4, 5]. However, these expert opinions have not been supported by scientific studies. Aiming to improve the anatomical outcome, we developed double-layered anterior colporrhaphy (DAC) in which a continuous suture is followed by traditional sutures. Wound surface and risk of hematoma are thought to be reduced subsequently.

We carried out a study on patients who underwent DAC and vaginal hysterectomy. In the video we demonstrate the different steps of DAC. Furthermore, we precisely describe the operation techniques, perioperative care and procedures. With this work we want to contribute to the development and standardization of native tissue anterior repair.

Patients and methods

The retrospective study included women treated by DAC with vaginal hysterectomy and apical fixation between January 2018 and August 2019. The institutional ethics committee gave approval, and registration followed in the German Clinical Trials Register (https://apps.who.int/trialsearch/) with trial-ID DRKS00021807.

Inclusion criteria were > 12 months after operation for ≥ stage 3 cystocele and ≥ stage 2 uterine (or cervical) prolapse (according to the Pelvic Organ Prolapse Quantification system [6]). Exclusion criteria were any other concurrent or previous pelvic floor or urinary incontinence surgery.

Primary outcome was anatomic cure defined as prolapse < stage 2. Secondary outcomes were complication rate, resolution of postvoid residual urine (PVR), reoperation for symptomatic recurrence and patient satisfaction.

Follow-up included a clinical gynecologic examination, introital sonography, catheterization for quantification of PVR, assessment of subjective results using the German Pelvic Floor Questionnaire [7] and a response scale (Likert) for postoperative quality of life (QoL).

Surgical technique and perioperative procedures

DAC and vaginal hysterectomy (and cervix extirpation) with apical fixation are standardized procedures in our clinic. We will omit the description of vaginal hysterectomy here as it was previously published by our group [8, 9]. Following hysterectomy, DAC is performed while the epithelium of the vaginal vault is still open. Before incision, 10 ml of Xylonest® 0.5% with adrenaline (prilocaine 5 mg/ml and epinephrine 4 μg/ml) divided into four doses is infiltrated paravaginally. The vaginal wall is tunneled and opened in the midline from the vaginal vault up to the urethrovesical junction using scissors. The pubocervical fascia is separated from the vaginal wall, first using scissors and then by blunt preparation up to the lateral sulci (arcus tendineus fasciae pelvis). Importantly, the fascia does remain on the bladder. The key difference between DAC and AC is the following unlocked continuous suture [Ethicon® coated Vicryl™ (polyglactin 910), braided absorbable suture 0]. It starts at the level of the urethrovesical junction and incorporates on each side half of the fascia to close the midline defect.

Afterwards, the traditional AC procedure is performed. Starting with a suture (Coated Vicryl™, 0) at the vesicouterine ligaments, the fascia is taken as laterally as possible and plicated by interrupted horizontally oriented sutures with a distance of 0.5–1.0 cm between sutures. The vaginal epithelium is subtly trimmed until the tunica muscularis becomes visible (to include this layer into the suture) and as far as the vaginal width allows. The colpotomy is closed without tension with a locked continuous suture [Ethicon® Monocryl™ (poliglecaprone 25), monofilament absorbable suture 3-0]; the epithelium of the vaginal vault is closed with 2–4 interrupted sutures (Coated Vicryl™, 0).

Operation is performed under general anesthesia. A single dose of cefazolin 2 g iv is administered 10 min preoperatively. Postoperatively, a transurethral Foley catheter and a vaginal pack with estriol gel are placed for 24 h. Intermittent catheterization is used in case of > 150 ml PVR (bladder scanner).

Results

One hundred one patients were eligible for the study. Sixty patients attended follow-up with a median time of 19.3 months. Anatomical cure was achieved in 49 cases (81.7%) of cystocele (point Aa, Ba) and in 59 cases (98.3%) of vaginal vault prolapse (point C). Main outcomes are listed in Table 1. Reasons for not participating were concerns due to the COVID-19 pandemic (n = 12), refusal (n = 8), distance to the hospital (n = 7) and other diseases (n = 7). In addition, several patients could not be contacted (n = 7).

Table 1

Descriptive analysis of the study cohort

Parameter	Category	DAC n (%)/med (IQR)
Operation		60 (100%)
Age at operation (years)		66 (58–71)
Body mass index at operation		25.1 (22.5–27.5)
Parity		2 (1–2)
Preoperative Aa, Ba (POP-Q)	Stage 3	55 (91.7%)
	Stage 4	5 (8.3%)
Preoperative C (POP-Q)	Stage 2	26 (43.3%)
	Stage 3	31 (51.7%)
	Stage 4	3 (5%)
Preoperative PVR ≥ 80 ml	No	34 (56.7%)
	Yes	26 (43.3%)
Time for surgery (min)		55 (45–65)
Subvesical hematoma 2 days postoperative	No	51 (85%)
	Yes	9 (15%)
Time to follow-up (months)		19.3 (16.1–25.5)
Postoperative Aa, Ba (POP-Q)	Stage 0	7 (11.7%)
	Stage 1	42 (70%)
	Stage 2	11 (18.3%)
Cure rate	Stage 0–1	49 (81.7%)
Recurrent cystocele	Stage 2	11 (18.3%)
Postoperative C (POP-Q)	Stage 0	55 (91.7%)
	Stage 1	4 (6.7%)
	Stage 3	1 (1.7%)
Postoperative tvl (cm)		8 (7.5–9)
Postoperative PVR ≥ 80 ml	No	55 (91.7%)
	Yes	5 (8.3%)
Postoperative German Pelvic Floor Questionnaire, prolapse domain
Foreign body sensation	Never	52 (86.7%)
	Occasionally	6 (10%)
	Frequently	1 (1.7%)
	Daily	1 (1.7%)
Sensation of vaginal bulge	Never	47 (78.3%)
	Occasionally	9 (15%)
	Frequently	2 (3.3%)
	Daily	2 (3.3%)
Manual repositioning for micturition	Never	60 (100%)
Manual repositioning for defecation	Never	59 (98.3%)
	Occasionally	1 (1.7%)
Psychological strain	Not at all	50 (83.3%)
	Slightly	8 (13.3%)
	Moderately	2 (3.3%)
Postoperative quality of life (Likert)	Much better	45 (75%)
	Better	10 (16.7%)
	Same	4 (6.7%)
	Worse	1 (1.7%)
	Much worse	0 (0%)

DAC = double-layered anterior colporrhaphy, IQR = interquartile range, med = median, n = number, POP-Q = Pelvic Organ Prolapse Quantification, PVR = postvoid residual urine, tvl = total vaginal length

One operation was cervix extirpation after laparoscopic-assisted supracervical hysterectomy (LASH) 10 years before, and in 12 cases additional procedures (adnexectomy, salpingectomy, adhesiolysis, open supraumbilical hernia repair) were performed.

There were no cases of ureteral, bladder or bowel injury during operation. One patient with solitary kidney, renal insufficiency and anticoagulation therapy (paused for operation) was reoperated the same day for a retroperitoneal hematoma (originating from the hysterectomy wound) and therefore beginning hydronephrosis. The hematoma was removed by abdominal-pararectal incision; no sutures had to be opened. There were no sequelae.

Preoperatively, 26 (43.3%) patients had PVR ≥ 80 ml (sonographically). After DAC, five patients showed PVR ≥ 80 ml at follow-up (minimum 100 ml, maximum 225 ml, catheterization) (Table 1). Each had PVR before surgery, one patient only 50 ml. Including the latter, resolution of PVR was achieved in 81.4% of patients.

No patient was reoperated for prolapse. One patient with preoperative mixed urinary incontinence received transurethral bulking agent (Bulkamid®, Axonics®), indicated at follow-up.

The response scale for postoperative QoL indicates an overall improvement (Table 1). Of the four patients with no change in QoL, all described stress and/or urge urinary incontinence; one patient additionally showed a recurrent cystocele and one patient a vaginal vault prolapse stage 3 and rectocele stage 3. One patient with decreased QoL suffered from stress urinary incontinence and pollakiuria.

Conclusion

The aim of this work was to investigate the outcome after DAC and to give a detailed description of the procedure. A high anatomical cure rate, frequent resolution of PVR and high patient satisfaction were observed. No organ injury or reoperation for hematoma due to DAC occurred. Throughout the investigated period, no reoperation for prolapse was required. One limitation of the study is the loss of 41% of patients to follow-up, which we consider acceptable given the retrospective design and the pandemic circumstances. Nonetheless, the lost patients might alter the results noticeably. A strength of our study is the high number of patients operated over a relatively short period, ensuring that the observed outcome is representative for the procedure detailed here. Furthermore, exclusion of other concurrent pelvic floor surgery prevents bias. With our video and detailed description of technique and procedures, surgeons can reproduce the operation and comparison between methods becomes feasible. Randomized controlled trials should follow.

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